Uncomplicated Skin and Soft Tissue Infections Caused by C... | NCT00730028

ID	Type	Description	Link
UCSF CA-MRSA

Description Module

Detailed Description

Clinical practice in the treatment of community-onset skin and soft tissue infections (SSTI) has not kept pace with the emergence of methicillin-resistant Staphylococcus aureus (MRSA) in the community. This clinical trial will evaluate clindamycin (CLINDA) and trimethoprim-sulfamethoxazole (TMP-SMX) and wound care for the outpatient management of uncomplicated skin and soft tissue infection (uSSTI) in 3 metropolitan areas, Chicago, Los Angeles, and San Francisco, cities with high prevalence of community acquired (CA)-MRSA. This is a phase IIb multicenter, stratified, randomized, double-blind trial in which enrolled subjects with abscess or cellulitis will be treated with CLINDA, TMP-SMX, or placebo. Participants will include 1310 non-immunocompromised out-patients age 6 months to 85 years with SSTIs not requiring hospital admission. Subjects will undergo a screening/baseline evaluation, including determination of presence and size of abscess and/or presence of cellulitis. Subjects will then be randomized to receive treatment with either CLINDA, TMP-SMX, or placebo depending on whether they have: a larger drainable abscess, defined as greater than 5 cm in diameter in adults and as greater than 3 cm in diameter for ages 6-11 months, greater than 4 cm for ages 1-8 years, and greater than 5 cm for age 9 years and older; a limited drainable abscess, defined as less than or equal to 5 cm for adults and as less than or equal to 3 cm for ages 6-11 months, less than or equal to 4 cm for ages 1-8 years, and less than or equal to 5 cm for age 9 years and older; or cellulitis or erysipelas only. If the diameter of the abscess greater than 5 cm (smaller for children depending on age) or 2 or more sites of skin infection are present the subject will be randomized (1:1) to 10 days of therapy with TMP-SMX or CLINDA. If the diameter of the abscess less than or equal to 5 cm (smaller for children depending on age) then the subject will be randomized (1:1:1) to TMP-SMX, CLINDA or placebo for 10 days. Subjects with cellulitis or erysipelas only will be randomized (1:1) to TMP-SMX or CLINDA for 10 days. Subjects will be provided study drug, instructed in its use, and scheduled for 4 follow-up visits including: wound check (24-48 hours after enrollment); end of therapy (48 hours after completion of therapy); test of cure (7-10 days after completion of therapy); and a final visit at one month after completion of therapy. The primary objectives of this study are: to compare the cure rate of CLINDA to that of TMP-SMX for the treatment of patients with cellulitis or larger abscess at the Test of Cure (TOC) visit and to compare the cure rate of CLINDA, TMP-SMX, and placebo, each in conjunction with surgical drainage for the treatment of subjects with limited abscess at the TOC visit.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Limited Abscess	Experimental	Limited abscess with or without cellulitis less than or equal to 5 cm in diameter will be randomized to receive a 10-day course a) TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children; or b) CLINDA 300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children; or c) placebo two capsules three times daily.	Drug: Trimethoprim-sulfamethoxazole Other: Placebo Drug: Clindamycin
Cellulitis or Larger Abscess	Experimental	Subjects with cellulitis only or abscess > 5 cm in diameter, or with 2 or more sites of skin infection will be randomized to receive a 10-day course a) TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children; or b) CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.	Drug: Trimethoprim-sulfamethoxazole Drug: Clindamycin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trimethoprim-sulfamethoxazole	Drug	Trimethoprim-sulfamethoxazole (TMP-SMX) will be administered orally at a dose of 160 mg TMP and 800 mg SMX (as 2 single strength over encapsulated tablets) twice daily (adult or child > 40 kg dose) or 8-10 mg TMP, 40-50 mg SMX per kg daily, divided into 2 daily doses (child < 40 kg dose). Study drug will be administered for 10 days.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Evaluable Population.	Clinical failure is defined as the occurence of any of the following: Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure. Occurrence of a SSTI at another site other than the site(s) under study. Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours. Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit. Unplanned surgical procedure for the infection under study at any time through the TOC visit. Hospitalization for treatment of active or invasive infection at any time through the TOC visit.	Test of cure (TOC) (7-10 days after completion of therapy)
Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Intent-to-Treat (ITT) Population.	Clinical failure is defined as the occurence of any of the following: Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure. Occurrence of a SSTI at another site other than the site(s) under study. Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours. Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit. Unplanned surgical procedure for the infection under study at any time through the TOC visit. Hospitalization for treatment of active or invasive infection at any time through the TOC visit.	Test of cure (TOC) (7-10 days after completion of therapy)

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants Reporting Adverse Events.	Subjects were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 6 months to 85 years.
Able to complete the informed consent process or, if a minor, a parent or guardian who is able to complete the informed consent process; an assent form also will be completed for children age 7 and older.
Willing and able to complete the study protocol, study-related activities, and visits.
Diagnosis of uncomplicated skin and soft tissue infection (uSSTI), either cellulitis (defined as an inflammation of skin and associated skin structures) or abscess (defined as a circumscribed collection of pus), evidenced by at least 2 of the following localized signs or symptoms on the skin for at least 24 hours:
1. Erythema
2. Swelling or induration
3. Local warmth
4. Purulent drainage
5. Tenderness to palpation or pain
Able to take oral antibiotic therapy, either in pill or suspension form.

Exclusion Criteria:

Hospital in-patient.
Hospitalization within the prior 14 days.
Residence in a long-term skilled nursing facility.
Requirement for hospitalization for skin infection or other condition.
Previous enrollment in this protocol.
Participation in another clinical trial within the previous 30 days.
Superficial skin infection only, including:
1. Impetigo
2. Ecthyma
3. Folliculitis
4. Infections that have a high cure rate after surgical incision alone (such as isolated furunculosis) or after topical or local measures
Unstable psychiatric or psychological condition rendering the subject unlikely to be cooperative or to complete study requirements.
Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with the adherence or subject compliance with study requirements.
Systolic blood pressure > 180 mm Hg.
Systolic blood pressure (SBP) less than an age-specific critical value:
1. Age 6 - 11 months: < 70 mm Hg
2. Age 1 to 8 years: < 80 mm Hg
3. Age 9 to 17 years: < 90 mm Hg
4. Age greater than or equal to 18 years: < 90 mm Hg
Heart rate less than 45 beats per minute (BPM).
Heart rate greater than an age-specific critical value:
1. Age 6 - 11 months: > 140 BPM
2. Age 1 to 8 years: > 120 BPM
3. Age 9 to 17 years: > 120 BPM
4. Age greater than or equal to 18 years: > 120 BPM.
Oral temperature (or equivalent rectal, tympanic membrane, axillary) less than 35.5 degrees Celsius (95.9 degrees Fahrenheit).
Oral temperature (or equivalent rectal, tympanic membrane, axillary) greater than age-specific critical value:
1. Age 6 - 11 months: > 38.0 degrees Celsius (100.4 degrees Fahrenheit)
2. Age 1 to 8 years: > 38.5 degrees Celsius (101.3 degrees Fahrenheit)
3. Age 9 to 17 years: > 38.5 degrees Celsius (101.3 degrees Fahrenheit)
4. Age greater than or equal to 18 years: > 38.5 degrees Celsius (101.3 degrees Fahrenheit).
Documented human or witnessed animal bite in the past 30 days at the site of infection.
Systemic antibacterial therapy with antistaphylococcal activity within the prior 14 days.
The following concomitant medications: warfarin, phenytoin, methotrexate, rosiglitazone or sulfonylureas and systemically administered antibacterial agents with activity against staphylococci.
Diagnosed or suspected disseminated or severe Staphylococcus aureus or group A streptococcal (GAS) infection, including lymphangitic spread of skin infection, septicemia, bacteremia, pneumonia, endocarditis, osteomyelitis, septic arthritis, gangrene, necrotizing fasciitis, myositis, or other serious infections.
Infection at an anatomical skin site requiring specialized management or specialized antimicrobial therapy, including:
1. Periauricular or orbital infection
2. Perirectal infection
3. Suspected deep space infection of the hand or foot
4. Genital infection
5. Mastitis
6. Bursitis
Radiographic evidence or suspicion of gas in the tissue or foreign body infection (note: radiography is not required for screening and can be performed at the discretion of the treating physician).
Gastrointestinal symptoms such as nausea, vomiting, or diarrhea of a severity that would preclude consumption of oral antibiotics.
Hypersensitivity or history of allergic reaction to study drug.
History of glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Third trimester pregnancy: pregnant women must have gestational age estimated by an objective means, e.g. ultrasound, fundal height, and women who are within 4 weeks of the third trimester of pregnancy, defined as week 27 of pregnancy, are not eligible.
Currently breast feeding.
Severe or morbid obesity with a body mass index (BMI) >40 kg/m^2.
Complicated skin or soft tissue infection, such as:
1. Catheter or catheter site infection within 30 days of placement
2. Surgical site infection
3. Known or suspected prosthetic device infection
4. Suspected Gram-negative or anaerobic pathogen
5. Unusual exposure history (e.g., underwater injury, fish-tank exposure, heavy soil exposure, etc)
6. Infection at the site of an area of underlying skin disease such as chronic eczema, psoriasis, atopic dermatitis, or chronic venous stasis
History of underlying immunocompromising condition or immunodeficiency, for example:
1. Diabetes mellitus
2. Chronic renal failure, creatinine clearance <30 ml/min
3. Renal dialysis within the past 180 days
4. Human immunodeficiency virus (HIV)-positive with either cluster of differentiation (CD)4 count <200 or <4 percent CD4 in the past 180 days or HIV-positive and no documented CD4 count in the past 4 months
5. Organ or bone marrow transplantation (ever), immunosuppressive therapy within the past 180 days, severe liver disease
6. Other serious underlying disease, as determined by the treating physician or the investigator

Facility	Status	City	State	ZIP	Country	Contacts
San Francisco General Hospital - Infectious Diseases		San Francisco	California	94110-3518	United States

PubMed Identifier	Type	Citation	Retractions
25785967	Result	Miller LG, Daum RS, Creech CB, Young D, Downing MD, Eells SJ, Pettibone S, Hoagland RJ, Chambers HF; DMID 07-0051 Team. Clindamycin versus trimethoprim-sulfamethoxazole for uncomplicated skin infections. N Engl J Med. 2015 Mar 19;372(12):1093-103. doi: 10.1056/NEJMoa1403789.
28657870	Derived	Daum RS, Miller LG, Immergluck L, Fritz S, Creech CB, Young D, Kumar N, Downing M, Pettibone S, Hoagland R, Eells SJ, Boyle MG, Parker TC, Chambers HF; DMID 07-0051 Team. A Placebo-Controlled Trial of Antibiotics for Smaller Skin Abscesses. N Engl J Med. 2017 Jun 29;376(26):2545-2555. doi: 10.1056/NEJMoa1607033.

ID	Title	Description
FG000	Cellulitis or Larger Abscess - Clindamycin	Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.

Arm/Group Information

ID	Title	Description
BG000	Cellulitis or Larger Abscess - Clindamycin	Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
BG001	Cellulitis or Larger Abscess - TMP-SMX	Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
BG002	Limited Abscess - Clindamycin	Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
BG003	Limited Abscess - TMP-SMX	Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
BG004	Limited Abscess - Placebo	Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.
BG005	Total	Total of all reporting groups

Units	Counts
Participants	BG000264 BG001260 BG002266 BG003263 BG004257 BG0051310

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

Primary

Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Evaluable Population.

Clinical failure is defined as the occurence of any of the following:

Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure.
Occurrence of a SSTI at another site other than the site(s) under study.
Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours.
Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit.
Unplanned surgical procedure for the infection under study at any time through the TOC visit.
Hospitalization for treatment of active or invasive infection at any time through the TOC visit.

The efficacy evaluable population was comprised of all participants who had outcomes determined at the Test of Cure (TOC) visit.

Posted

Number

95% Confidence Interval

percentage of participants

Test of cure (TOC) (7-10 days after completion of therapy)

ID	Title	Description
OG000	Cellulitis or Larger Abscess - Clindamycin	Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
OG001	Cellulitis or Larger Abscess - TMP-SMX	Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
OG002	Limited Abscess - Clindamycin	Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
OG003	Limited Abscess - TMP-SMX	Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
OG004	Limited Abscess - Placebo	Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter in adults and children age 9 years and older, < 4 cm in diameter in children age 1 to 8 years, or < 3 cm in diameter in children age 6 to 12 months were treated with placebo three times daily.

Units	Counts
Participants	OG000237 OG001229 OG002238 OG003

Title

Denominators

Categories

Title	Measurements
	OG00089.5(85.2 to 93.7) OG00188.2(83.7 to 92.7) OG00292.9(89.3 to 96.4) OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Primary null hypothesis: Clindamycin and TMP-SMX have equal rates of cure in the treatment of cellulitis/larger abscess at the Test of Cure (TOC) visit.	Fisher Exact		0.7688	Adjustments for multiple comparisons were made using a Bonferroni correction.	Mean Difference (Final Values)	-1.2			2-Sided	95	-7.6	5.1			The mean difference is determined by the cure rate of TMP-SMX minus Clindamycin.	No	Superiority or Other

Secondary

Number of Participants Reporting Adverse Events.

Subjects were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events.

Participants who received treatment with either clindamycin or TMP/SMX in the cellulitis or larger abscess group and participants who received treatment with either clindamycin, TMP/SMX, or placebo in the limited abscess group.

Posted

Number

participants

End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU)

ID	Title	Description
OG000	Cellulitis or Larger Abscess - Clindamycin	Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
OG001	Cellulitis or Larger Abscess - TMP-SMX	Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.

Secondary

Number of Participants Reporting Adverse Events That Are Treatment Limiting.

Participants were issued a Memory Aid to record symptoms for 10 days post product administration. At study visits, the staff reviewed the memory aid and elicited as much information as possible about any reported symptoms. Occurrence of adverse events was solicited in the memory aid and during study visits. Reported symptoms, both solicited and unsolicited, were recorded as Adverse Events. For these results, adverse events that resulted in discontinuation of study treatment for the participant were considered treatment limiting.

Posted

Number

participants

End of Treatment (EOT) (48 hours after completion of therapy); Test of Cure (TOC) (7-10 days after completion of therapy); One Month Follow-up Visit (OMFU)

ID	Title	Description
OG000	Cellulitis or Larger Abscess - Clindamycin	Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
OG001	Cellulitis or Larger Abscess - TMP-SMX

Primary

Percentage of Participants Achieving Clinical Cure, Defined as Absence of Clinical Failure, in the Intent-to-Treat (ITT) Population.

Clinical failure is defined as the occurence of any of the following:

Lack of resolution at the Test of Cure (TOC) visit in any or all of the following: erythema, tenderness, purulent drainage, swelling, and local warmth. Erythema or tenderness that was considered due the surgical therapy itself (incision and drainage), was not considered to be indicative of clinical failure.
Occurrence of a SSTI at another site other than the site(s) under study.
Intolerance of study medication or a treatment-limiting adverse reaction necessitating discontinuation of study drug within the first 48 hours.
Administration of other antimicrobial therapy for treatment of a SSTI at any time through the TOC visit.
Unplanned surgical procedure for the infection under study at any time through the TOC visit.
Hospitalization for treatment of active or invasive infection at any time through the TOC visit.

The ITT population was comprised of all participants enrolled in the trial.

Posted

Number

95% Confidence Interval

percentage of participants

Test of cure (TOC) (7-10 days after completion of therapy)

ID	Title	Description
OG000	Cellulitis or Larger Abscess - Clindamycin	Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.

Secondary

Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Evaluable Population.

Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure.

The efficacy evaluable population was comprised of all participants who had outcomes determined at the EOT visit.

Posted

Number

95% Confidence Interval

percentage of participants

EOT visit within 48 hours of completion of therapy

ID	Title	Description
OG000	Cellulitis or Larger Abscess - Clindamycin	Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
OG001	Cellulitis or Larger Abscess - TMP-SMX	Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
OG002

Secondary

Percentage of Participants Achieving Clinical Cure at the End of Treatment (EOT) Visit for the Intent-to-Treat (ITT) Population.

Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure.

All participants enrolled in the trial.

Posted

Number

95% Confidence Interval

percentage of participants

EOT visit within 48 hours of completion of therapy

ID	Title	Description
OG000	Cellulitis or Larger Abscess - Clindamycin	Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
OG001	Cellulitis or Larger Abscess - TMP-SMX	Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.
OG002	Limited Abscess - Clindamycin

Secondary

Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Evaluable Population.

Measures of clinical cure and clinical failure are the same as those defined for the primary efficacy outcome measure, with one addition. At the OMFU, relapse (the return of the original infection after initial improvement) or recurrence (return of skin infection at original site after cure of original infection) of SSTI was scored as clinical failure.

The efficacy evaluable population was comprised of all participants who had outcomes determined at the OMFU visit.

Posted

Number

95% Confidence Interval

percentage of participants

OMFU visit

ID	Title	Description
OG000	Cellulitis or Larger Abscess - Clindamycin	Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
OG001	Cellulitis or Larger Abscess - TMP-SMX	Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.

Secondary

Percentage of Participants Achieving Clinical Cure at the One Month Follow-up (OMFU) Visit for the Intent-to-Treat (ITT) Population.

All participants enrolled in the trial.

Posted

Number

95% Confidence Interval

percentage of participants

OMFU visit

ID	Title	Description
OG000	Cellulitis or Larger Abscess - Clindamycin	Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.
OG001	Cellulitis or Larger Abscess - TMP-SMX	Participants with cellulitis only or abscess > 5 cm in diameter in adults and children age 9 years and older, > 4 cm in diameter in children age 1 to 8 years, or > 3 cm in diameter in children age 6 to 12 months, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cellulitis or Larger Abscess - Clindamycin	Participants with cellulitis only or abscess > 5 cm in diameter, or with 2 or more sites of skin infection were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.	4	264	59	264
EG001	Cellulitis or Larger Abscess - TMP-SMX	Participants with cellulitis only or abscess > 5 cm in diameter, or with 2 or more sites of skin infection were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.	5	260	72	260
EG002	Limited Abscess - Clindamycin	Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with CLINDA300 mg three times daily for adults; 25-30 mg/kg/day divided three times daily for children.	0	266	61	266
EG003	Limited Abscess - TMP-SMX	Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with TMP-SMX 160/800 mg twice daily for adults; 8-10 mg/kg of TMP, 40-50 mg/kg of SMX twice daily for children.	6	263	52	263
EG004	Limited Abscess - Placebo	Participants with limited abscess with or without cellulitis less than or equal to 5 cm in diameter were treated with placebo three times daily.	2	257	60	257

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cellulitis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected264 at risk EG0012 events2 affected260 at risk EG0020 events0 affected266 at risk EG0031 events1 affected263 at risk EG0040 events0 affected257 at risk
Abscess	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected264 at risk EG0010 events0 affected260 at risk EG0020 events0 affected266 at risk EG003
Perirectal Abscess	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected264 at risk EG0010 events0 affected260 at risk EG0020 events0 affected266 at risk EG003
Thermal Burn	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected264 at risk EG0010 events0 affected260 at risk EG0020 events0 affected266 at risk EG003
Mental Disorder	Psychiatric disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected264 at risk EG0011 events1 affected260 at risk EG0020 events0 affected266 at risk EG003
Crohn's Disease	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected264 at risk EG0011 events1 affected260 at risk EG0020 events0 affected266 at risk EG003
Induration	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected264 at risk EG0011 events1 affected260 at risk EG0020 events0 affected266 at risk EG003
Injury	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected264 at risk EG0010 events0 affected260 at risk EG0020 events0 affected266 at risk EG003
Drug Eruption	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected264 at risk EG0010 events0 affected260 at risk EG0020 events0 affected266 at risk EG003
Status Asthmaticus	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected264 at risk EG0010 events0 affected260 at risk EG0020 events0 affected266 at risk EG003
Pneumonia	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected264 at risk EG0010 events0 affected260 at risk EG0020 events0 affected266 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected264 at risk EG0010 events0 affected260 at risk EG0020 events0 affected266 at risk EG003

ID	Term
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D012874	Skin Diseases, Infectious
D013492	Suppuration
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D013420	Sulfamethoxazole
D000096926	Benzenesulfonamides
D013449	Sulfonamides
D000577	Amides
D009930	Organic Chemicals
D013424	Sulfanilamides
D000814	Aniline Compounds
D000588	Amines
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D013450	Sulfones
D013457	Sulfur Compounds
D014295	Trimethoprim
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D004338	Drug Combinations
D004364	Pharmaceutical Preparations
D008034	Lincomycin
D055231	Lincosamides
D011759	Pyrrolidines
D006027	Glycosides
D002241	Carbohydrates

ID	Term
D013203	Staphylococcal Infections
D002481	Cellulitis
D000038	Abscess

ID	Term
D015662	Trimethoprim, Sulfamethoxazole Drug Combination
D002981	Clindamycin