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The purpose of this study is to determine the optimal outpatient treatment strategy of uncomplicated skin and soft tissue infection (SSTI) in areas of the United States where the prevalence of Community-Acquired Methicillin-Resistant Staphylococcus (S.) aureus (CA-MRSA) is high. Infection with the S. aureus bacteria that is resistant to antibiotics is a cause of SSTIs. Three oral antibiotics will be tested for off patent treatment. Patients will receive Trimethoprim/Sulfamethoxazole (TMP/SMX), placebo (substance containing no medication), clindamycin, or cephalexin or some combination of these. The study population will include 2,235 volunteers, children 13 years of age and over and adults presenting to 5 large urban Emergency Departments. Therapy for acute uncomplicated SSTIs, including abscess, infected wound, and cellulitis will start on the day of enrollment. Participants may be involved in study related procedures for about 9 weeks.
Community-acquired methicillin-resistant Staphylococcus aureus (CA-MRSA) has recently emerged as a cause of skin and soft-tissue infection (SSTI). In the current era of increasing CA-MRSA infections, the outpatient management of SSTIs has not been well studied. This will be a clinical trial to evaluate oral off-patent antibiotics for outpatient treatment of patients with any of the 3 main types of acute uncomplicated SSTI, i.e., abscesses, infected wounds, and cellulitis. Upon enrollment, subjects will be stratified by type of infection, and then randomized to various treatments. Subjects with an acute uncomplicated cutaneous abscess receiving incision and drainage (I&D) will be treated with Trimethoprim/Sulfamethoxazole (TMP/SMX) or placebo to determine whether the addition of an antibiotic with activity against CA-MRSA is more clinically efficacious than I&D alone. Subjects with an acute wound infection will be treated with TMP/SMX or clindamycin to determine if clindamycin, an antibiotic with activity against CA-MRSA, methicillin-susceptible Staphylococcus aureus (MSSA), and streptococci is more clinically efficacious than TMP/SMX, an antibiotic with activity against CA-MRSA and MSSA. Subjects with acute cellulitis will be treated with cephalexin/TMP/SMX or cephalexin/placebo to determine if cephalexin/TMP/SMX is more clinically efficacious than cephalexin alone. The primary objectives for each type of SSTI studied are to compare the cure rates in the per protocol (PP) population. Secondary objectives provide additional means of assessment for the clinical efficacy of the employed interventions and resolution of the infection and include describing microbiological cure, change in the dimension of erythema, composite cure, surgical procedures, invasive and recurrent infections, infections in household contacts, and time to normal activity and until analgesics are no longer used at various times in the PP/ modified intent-to-treat (mITT) populations. This is a multi-center, randomized, double-blind clinical trial in which subjects will be stratified by the type of infection and then randomized to various 7-day oral antibiotic treatments, including placebo-controlled and comparative designs. The study population will include children 13 years of age and over and adults, who weigh greater than or equal to 40 kg presenting to 5 large urban emergency departments. Therapy will start on the day of enrollment. Subjects will be evaluated upon enrollment, at 2-3 days after enrollment (OTV), at 1-3 days after the end-of-therapy (EOT), at 7-14 days after the end-of-therapy (TOC), and at 6-8 weeks after the end-of-therapy (EFV).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMP/SMX vs. Placebo | Experimental | Subjects with an acute uncomplicated cutaneous abscess will be randomized to receive either Trimethoprim/Sulfamethoxazole (TMP/SMX) (4 single strength pills, 80 mg/400 mg each, twice per day) or 4 placebo pills (twice per day). |
|
| TMP/SMX vs. Clindamycin | Experimental | Subjects with an acute uncomplicated wound infection will be randomized to receive Trimethoprim/Sulfamethoxazole (TMP/SMX) (4 single strength pills, 80 mg/400 mg each, twice per day, with alternating 1 identical placebo pill, twice per day) or clindamycin (300 mg, four times per day, with 3 placebo pills on alternating doses). |
|
| Cephalexin and TMP/SMX vs. Cephalexin | Experimental | Subjects with acute uncomplicated cellulitis will be randomized to receive cephalexin (500 mg, four times per day) and Trimethoprim/Sulfamethoxazole (TMP/SMX) (4 single strength pills, 80 mg/400 mg each, twice per day) or cephalexin (500 mg, four times per day) and placebo (4 pills, twice per day). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cephalexin | Drug | 500 mg, four times per day. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population | Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment. | Days 14-21 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment. |
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Inclusion Criteria:
Adult or child 13 years of age and older (who weighs greater than or equal to 40 kg);
Have a skin and soft tissue infection (SSTI) with all three local findings of erythema (> 2 cm across the lesion or from a discrete wound edge), tenderness, and swelling/induration. Fever, leukocytosis, and lymphangitis will be noted, but are not enrollment criteria. SSTI with these local findings will be further categorized and defined as one of:
Abscess - a fluctuant and/or indurated lesion, or findings of a fluid-filled cavity on soft tissue ultrasound evaluation that, when opened reveals purulent material, receiving incision and drainage (I&D) (considered standard care for abscess) and having a minimum diameter (along any axis) of at least 2 cm (measured from the borders of induration, if a fluctuant lesion, or borders of the abscess cavity on ultrasound, if not fluctuant).
Note: Although I&D of an abscess is considered standard care (i.e., patients will receive I&D whether or not they are enrolled in the study), the procedure may be performed after enrollment into the study so that prior measurements of the area of erythema and swelling/induration can be obtained unless it is an occult abscess in which the I&D will be performed prior to enrollment to verify infection type and ensure correct classification of the subject.
Infected Wound - a wound (defined as any apparent break in the skin) with any apparent drainage limited in depth to only involving skin and subcutaneous tissue, including sutured cutaneous wounds not involving intra-abdominal surgeries contaminated with bacterial or bowel contents (e.g., colon surgery and empyema drainage), and
Cellulitis - an area of erythema without the presence of a wound with drainage or abscess; Cellulitis associated with an abscess will be categorized as an abscess. Cellulitis associated with an infected wound will be classified as an infected wound. Patients with cellulitis and an abscess less than 2 cm will be excluded. Infected wound associated with an abscess that may require I&D, will be classified as an infected wound.
Have the infected lesion for 7 days or less duration;
Are to receive outpatient treatment at enrollment/baseline;
Express willingness and ability to be contacted and return for re-evaluation according to the study protocol;
Provide written informed consent (and for subjects ages 13-17, consent from their guardian and assent);
Negative pregnancy test for subjects who are women of childbearing potential.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maricopa Medical Center - Emergency Medicine | Phoenix | Arizona | 85008-4973 | United States | ||
| University of California Los Angeles - Olive View Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30926187 | Derived | Mower WR, Crisp JG, Krishnadasan A, Moran GJ, Abrahamian FM, Lovecchio F, Karras DJ, Steele MT, Rothman RE, Talan DA. Effect of Initial Bedside Ultrasonography on Emergency Department Skin and Soft Tissue Infection Management. Ann Emerg Med. 2019 Sep;74(3):372-380. doi: 10.1016/j.annemergmed.2019.02.002. Epub 2019 Mar 27. | |
| 28987525 |
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Participants were recruited between 13APR2009 and 16APR2013 from those who presented with an abscess, infected wound, or cellulitis at emergency departments at each of the clinical sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Abscess, Placebo | Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day. |
| FG001 | Abscess, TMP/SMX | Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Clindamycin |
| Drug |
300 mg, four times per day. |
|
| Placebo | Other | Placebo tablet administered orally. |
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| Trimethoprim-sulfamethoxazole | Drug | 4 single strength Trimethoprim/Sulfamethoxazole (TMP/SMX), 80 mg/400 mg each, twice per day. |
|
| Days 14-21 |
| Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. | Day 1 to Day 3-4 |
| Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. | Day 1 to Day 3-4 |
| Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. | Day 1 to Day 8-10 |
| Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. | Day 1 to Day 8-10 |
| Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. | Day 1 to Day 14-21 |
| Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. | Day 1 to Day 14-21 |
| Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population | Participants were categorized as composite clinical cure if they had resolution of all symptoms/signs of infection, or improvement to such an extent that no additional antibiotic therapy and/or surgical procedures were necessary. Participants were categorized as composite clinical failure if they had lack of resolution of all signs and symptoms of infection to such an extent that further antibiotic therapy and/or surgical procedures were necessary. | Day 14-21 |
| Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Participants were categorized for the microbiological outcome with Presumed eradication if they were not deemed a clinical failure through TOC. Those who were deemed a clinical failure through the TOC were classified as one of the following: Persistence=persistent growth of a pre-therapy pathogen; New infection=growth of a new pathogen and eradication of initial pathogen; Super-infection=growth of a new pathogen in addition to persistent growth of pre-therapy pathogen; Unclassified=no specimen for culture or growth of a pathogen in subsequent culture specimen of cellulitis participants, or for whom initial culture specimens were negative or were not obtained for infected wound and abscess participants; or Indeterminate=not meeting any one of the above microbiologic outcome criteria. | Day 14-21 |
| Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Per Protocol Population | All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized. | Day 1 through Day 14-21 |
| Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Intent to Treat Population | All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized. | Day 1 through Day 14-21 |
| Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Per Protocol Population | All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized. | Day 1 through Day 49-63 |
| Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Intent to Treat Population | All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized. | Day 1 through Day 49-63 |
| Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Per Protocol Population | Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure. | Day 1 through Day 14-21 |
| Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Intent to Treat Population | Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure. | Day 1 through Day 14-21 |
| Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Per Protocol Population | Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure. | Day 1 through Day 49-63 |
| Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Intent to Treat Population | Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure. | Day 1 through Day 49-63 |
| Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Per Protocol Population | Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized. | Day 1 through Day 14-21 |
| Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Intent to Treat Population | Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized. | Day 1 through Day 14-21 |
| Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Per Protocol Population | Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized. | Day 1 through Day 49-63 |
| Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Intent to Treat Population | Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized. | Day 1 through Day 49-63 |
| Number of Participants With Infections in Household Contacts Through the TOC Visit in the Per Protocol Population | At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized. | Day 1 through Day 14-21 |
| Number of Participants With Infections in Household Contacts Through the TOC Visit in the Intent to Treat Population | At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized. | Day 1 through Day 14-21 |
| Number of Participants With Infections in Household Contacts Through the EFV Visit in the Per Protocol Population | At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized. | Day 1 through Day 49-63 |
| Number of Participants With Infections in Household Contacts Through the EFV Visit in the Intent to Treat Population | At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized. | Day 1 through Day 49-63 |
| Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | All adverse events were recorded through the test of cure visit; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit. All AEs were assessed for association with the study product by a clinician and were considered associated with study product if the event was temporally related to the administration of the study product and no other etiology more likely explains the event. Associated adverse events are summarized by MedDRA System Organ Class. | Day 1 through Day 49-63 |
| Mean Days Missed From Normal Activities in the Per Protocol Population | As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period. | Day 1 through 14 |
| Mean Days Missed From Normal Activities in the Intent to Treat Population | As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period. | Day 1 through 14 |
| Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period. | Day 1 through 14 |
| Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period. | Day 1 through 14 |
| Sylmar |
| California |
| 91342-1437 |
| United States |
| Johns Hopkins University at Mount Washington - Emergency Medicine | Baltimore | Maryland | 21209-3652 | United States |
| Truman Medical Center - Hospital Hill | Kansas City | Missouri | 64108-2640 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140-5103 | United States |
| Talan DA, Moran GJ, Krishnadasan A, Abrahamian FM, Lovecchio F, Karras DJ, Steele MT, Rothman RE, Mower WR. Subgroup Analysis of Antibiotic Treatment for Skin Abscesses. Ann Emerg Med. 2018 Jan;71(1):21-30. doi: 10.1016/j.annemergmed.2017.07.483. Epub 2017 Oct 5. |
| 28535235 | Derived | Moran GJ, Krishnadasan A, Mower WR, Abrahamian FM, LoVecchio F, Steele MT, Rothman RE, Karras DJ, Hoagland R, Pettibone S, Talan DA. Effect of Cephalexin Plus Trimethoprim-Sulfamethoxazole vs Cephalexin Alone on Clinical Cure of Uncomplicated Cellulitis: A Randomized Clinical Trial. JAMA. 2017 May 23;317(20):2088-2096. doi: 10.1001/jama.2017.5653. |
| 27025829 | Derived | Talan DA, Lovecchio F, Abrahamian FM, Karras DJ, Steele MT, Rothman RE, Krishnadasan A, Mower WR, Hoagland R, Moran GJ. A Randomized Trial of Clindamycin Versus Trimethoprim-sulfamethoxazole for Uncomplicated Wound Infection. Clin Infect Dis. 2016 Jun 15;62(12):1505-1513. doi: 10.1093/cid/ciw177. Epub 2016 Mar 29. |
| 26962903 | Derived | Talan DA, Mower WR, Krishnadasan A, Abrahamian FM, Lovecchio F, Karras DJ, Steele MT, Rothman RE, Hoagland R, Moran GJ. Trimethoprim-Sulfamethoxazole versus Placebo for Uncomplicated Skin Abscess. N Engl J Med. 2016 Mar 3;374(9):823-32. doi: 10.1056/NEJMoa1507476. |
| FG002 | Infected Wound, TMP/SMX | Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day. |
| FG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| FG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| FG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
| COMPLETED |
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| NOT COMPLETED |
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The baseline analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Abscess, Placebo | Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day. |
| BG001 | Abscess, TMP/SMX | Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| BG002 | Infected Wound, TMP/SMX | Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day. |
| BG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| BG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| BG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
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| Secondary | Number of Participants With Clinical Cure as of the TOC Visit in the Intent to Treat Population | Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment. | All subjects who took at least one dose of study medication were included in the intent to treat population. | Posted | Number | participants | Days 14-21 |
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| Primary | Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population | Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment. | The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population. | Posted | Number | participants | Days 14-21 |
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| Secondary | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Per Protocol Population | The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. | The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population. | Posted | Number | participants | Day 1 to Day 3-4 |
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| Secondary | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the On-therapy Visit in the Intent to Treat Population | The area of erythema was measured in square centimeters at baseline and at the on-therapy visit. For each subject, the change in area was calculated as the area at on-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. | All subjects who took at least one dose of study medication were included in the intent to treat population. | Posted | Number | participants | Day 1 to Day 3-4 |
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| Secondary | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Per Protocol Population | The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. | The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population. | Posted | Number | participants | Day 1 to Day 8-10 |
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| Secondary | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the End-of-therapy Visit in the Intent to Treat Population | The area of erythema was measured in square centimeters at baseline and at the end-of-therapy visit. For each subject, the change in area was calculated as the area at end-of-therapy subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. | All subjects who took at least one dose of study medication were included in the intent to treat population. | Posted | Number | participants | Day 1 to Day 8-10 |
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| Secondary | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Per Protocol Population | The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. | The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population. | Posted | Number | participants | Day 1 to Day 14-21 |
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| Secondary | Number of Participants With Reduction in Erythema Dimensions by 5% Intervals at the TOC Visit in the Intent to Treat Population | The area of erythema was measured in square centimeters at baseline and at the TOC visit. For each subject, the change in area was calculated as the area at TOC subtracted from the area at baseline. The change in area was then divided by the original area to determine the proportional change. Participants were then categorized by reductions in 5% intervals, with participants whose erythema did not change or increased categorized as no reduction. | All subjects who took at least one dose of study medication were included in the intent to treat population. | Posted | Number | participants | Day 1 to Day 14-21 |
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| Secondary | Number of Participants by Composite Clinical Outcome at the TOC Visit in the Per Protocol Population | Participants were categorized as composite clinical cure if they had resolution of all symptoms/signs of infection, or improvement to such an extent that no additional antibiotic therapy and/or surgical procedures were necessary. Participants were categorized as composite clinical failure if they had lack of resolution of all signs and symptoms of infection to such an extent that further antibiotic therapy and/or surgical procedures were necessary. | The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population. | Posted | Number | participants | Day 14-21 |
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| Secondary | Number of Participants With Each Microbiological Outcome at the TOC Visit in the Per Protocol Population | Participants were categorized for the microbiological outcome with Presumed eradication if they were not deemed a clinical failure through TOC. Those who were deemed a clinical failure through the TOC were classified as one of the following: Persistence=persistent growth of a pre-therapy pathogen; New infection=growth of a new pathogen and eradication of initial pathogen; Super-infection=growth of a new pathogen in addition to persistent growth of pre-therapy pathogen; Unclassified=no specimen for culture or growth of a pathogen in subsequent culture specimen of cellulitis participants, or for whom initial culture specimens were negative or were not obtained for infected wound and abscess participants; or Indeterminate=not meeting any one of the above microbiologic outcome criteria. | The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population. | Posted | Number | participants | Day 14-21 |
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| Secondary | Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Per Protocol Population | All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized. | The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population. | Posted | Number | participants | Day 1 through Day 14-21 |
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| Secondary | Number of Participants Requiring Surgical Intervention Through the TOC Visit in the Intent to Treat Population | All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the test-of-cure visit are summarized. | All subjects who took at least one dose of study medication were included in the intent to treat population. | Posted | Number | participants | Day 1 through Day 14-21 |
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| Secondary | Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Per Protocol Population | All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized. | The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population. | Posted | Number | participants | Day 1 through Day 49-63 |
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| Secondary | Number of Participants Requiring Surgical Intervention Through the Extended Follow-up Visit (EFV) in the Intent to Treat Population | All surgical procedures such as incision and drainage (I&D) and debridement that were related to the current infection under study or significant to the health of the subject, except for the initial I&D of an abscess for participants in the abscess or infected wound arms, were recorded. Participants who required a surgical intervention between the initial enrollment (excluding the initial I&D as applicable) and the extended follow-up visit are summarized. | All subjects who took at least one dose of study medication were included in the intent to treat population. | Posted | Number | participants | Day 1 through Day 49-63 |
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| Secondary | Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Per Protocol Population | Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure. | The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population. | Posted | Number | participants | Day 1 through Day 14-21 |
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| Secondary | Number of Participants With Development of an Invasive Infection Through the TOC Visit in the Intent to Treat Population | Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure. | All subjects who took at least one dose of study medication were included in the intent to treat population. | Posted | Number | participants | Day 1 through Day 14-21 |
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| Secondary | Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Per Protocol Population | Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure. | The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population. | Posted | Number | participants | Day 1 through Day 49-63 |
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| Secondary | Number of Participants With Development of an Invasive Infection Through the EFV Visit in the Intent to Treat Population | Participants were evaluated for invasive infection, which included, but was not limited to, findings of severe sepsis/septic shock, endocarditis, pneumonia, necrotizing soft tissue, osteomyelitis, and bacteremia. A positive response to at least one finding was considered invasive infection for this outcome measure. | All subjects who took at least one dose of study medication were included in the intent to treat population. | Posted | Number | participants | Day 1 through Day 49-63 |
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| Secondary | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Per Protocol Population | Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized. | The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population. | Posted | Number | participants | Day 1 through Day 14-21 |
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| Secondary | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the TOC Visit in the Intent to Treat Population | Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the test-of-cure visit are summarized. | All subjects who took at least one dose of study medication were included in the intent to treat population. | Posted | Number | participants | Day 1 through Day 14-21 |
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| Secondary | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Per Protocol Population | Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized. | The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population. | Posted | Number | participants | Day 1 through Day 49-63 |
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| Secondary | Number of Participants Who Developed a Recurrent Infection at the Original Infection Site Through the EFV Visit in the Intent to Treat Population | Participants were evaluated for the development of a recurrent, or repeat, infection at the original infection site. Participants who were reported to have developed a recurrent infection though the extended follow-up visit are summarized. | All subjects who took at least one dose of study medication were included in the intent to treat population. | Posted | Number | participants | Day 1 through Day 49-63 |
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| Secondary | Number of Participants With Infections in Household Contacts Through the TOC Visit in the Per Protocol Population | At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized. | The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population. | Posted | Number | participants | Day 1 through Day 14-21 |
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| Secondary | Number of Participants With Infections in Household Contacts Through the TOC Visit in the Intent to Treat Population | At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the test-of-cure visit are summarized. | All subjects who took at least one dose of study medication were included in the intent to treat population. | Posted | Number | participants | Day 1 through Day 14-21 |
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| Secondary | Number of Participants With Infections in Household Contacts Through the EFV Visit in the Per Protocol Population | At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized. | The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population. | Posted | Number | participants | Day 1 through Day 49-63 |
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| Secondary | Number of Participants With Infections in Household Contacts Through the EFV Visit in the Intent to Treat Population | At each follow-up visit, participants were asked about history of skin infections in household members (e.g., similar skin infection in a family member). This outcome measure relied solely on participant reporting. Participants who reported having a family member with a similar infection though the extended follow-up visit are summarized. | All subjects who took at least one dose of study medication were included in the intent to treat population. | Posted | Number | participants | Day 1 through Day 49-63 |
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| Secondary | Number of Participants With Adverse Events Considered Associated With the Study Product by MedDRA System Organ Class | All adverse events were recorded through the test of cure visit; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit. All AEs were assessed for association with the study product by a clinician and were considered associated with study product if the event was temporally related to the administration of the study product and no other etiology more likely explains the event. Associated adverse events are summarized by MedDRA System Organ Class. | All subjects who took at least one dose of study medication were included in the intent to treat population. | Posted | Number | participants | Day 1 through Day 49-63 |
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| Secondary | Mean Days Missed From Normal Activities in the Per Protocol Population | As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period. | The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population. | Posted | Mean | Standard Deviation | days | Day 1 through 14 |
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| Secondary | Mean Days Missed From Normal Activities in the Intent to Treat Population | As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as participation in normal life activities. The maximum number of days assessed, 14, was assigned to participants who had not yet resumed normal activities by the end of the assessment period. | All subjects who took at least one dose of study medication were included in the intent to treat population. | Posted | Mean | Standard Deviation | days | Day 1 through 14 |
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| Secondary | Number of Participants Reporting 1-14 Days of Analgesic Use in the Per Protocol Population | As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period. | The analysis population is the per protocol population. All participants who met enrollment criteria, had none of the exclusion criteria, completed at least 75% of the first 5 days of antimicrobial therapy, and had physical follow-up at the Test of Cure (TOC) visit were included in the per protocol population. | Posted | Number | participants | Day 1 through 14 |
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| Secondary | Number of Participants Reporting 1-14 Days of Analgesic Use in the Intent to Treat Population | As a quality of life measure, participants maintained a memory aid from Day 1 to Day 14 to track measures such as use of other, non-study medications such as analgesics. Each participant is summarized by the last day of reported analgesic usage, from the start of treatment with study intervention. The maximum number of days assessed, 14, was assigned to participants who were still taking analgesic medications by the end of the assessment period. | All subjects who took at least one dose of study medication were included in the intent to treat population. | Posted | Number | participants | Day 1 through 14 |
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All adverse events were recorded through the test of cure visit at Day 14-21; serious adverse events and new and recurrent skin infections were recorded though the extended follow-up visit at Day 49-63.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Abscess, Placebo | Participants with an acute uncomplicated cutaneous abscess received 4 placebo pills twice per day. | 30 | 617 | 331 | 617 | ||
| EG001 | Abscess, TMP/SMX | Participants with an acute uncomplicated cutaneous abscess received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. | 21 | 630 | 345 | 630 | ||
| EG002 | Infected Wound, TMP/SMX | Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day. | 15 | 250 | 138 | 250 | ||
| EG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. | 11 | 249 | 127 | 249 | ||
| EG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. | 20 | 248 | 157 | 248 | ||
| EG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. | 21 | 248 | 149 | 248 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Breast abscess | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Bursitis infective | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Cellulitis staphylococcal | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Coccidioidomycosis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Lip injury | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
| |
| Acidosis | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Drug dependence | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David A. Talan, MD | Olive View-UCLA Medical Center | 818-364-3107 | dtalan@ucla.edu |
| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D002506 | Cephalexin |
| D002981 | Clindamycin |
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D014295 | Trimethoprim |
| D011743 | Pyrimidines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Clinical Failure |
|
| OG002 | Infected Wound, TMP/SMX | Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day. |
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day. |
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
| Infected Wound, TMP/SMX |
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day. |
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day. |
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day. |
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
| OG002 | Infected Wound, TMP/SMX | Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day. |
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day. |
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
| Infected Wound, TMP/SMX |
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day. |
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day.
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
Participants with an acute uncomplicated wound infection received Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day, with alternating 1 identical placebo pill, twice per day. |
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|
| OG003 | Infected Wound, Clindamycin | Participants with an acute uncomplicated wound infection received clindamycin as 300 mg pills, four times per day, with 3 placebo pills on alternating doses. |
| OG004 | Cellulitis, Cephalexin and TMP/SMX | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and Trimethoprim/Sulfamethoxazole (TMP/SMX) as 4 single strength pills of 80mg/400mg each, twice per day. |
| OG005 | Cellulitis, Cephalexin | Participants with acute uncomplicated cellulitis received cephalexin as 500 mg pills, four times per day, and 4 placebo pills, twice per day. |
|
|