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| ID | Type | Description | Link |
|---|---|---|---|
| DAP-HEOR-10-06 | Other Identifier | Cubist Study Number |
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This was a real-world, prospective, open-label, multicenter study in which participants were randomized (1:1) to receive intravenous (IV) vancomycin or IV daptomycin. The purpose of this study is to compare infection-related hospital length of stay, along with a number of participant-reported outcomes, between participants with complicated skin and soft tissue infection treated with daptomycin and vancomycin.
Eligible participants will be recruited within 24 hours of hospital admission for cSSSI due to suspected or documented Methicillin-resistant Staphylococcus Aureus (MRSA), and who are anticipated to require IV antibiotics effective against MRSA and at least 3 days of hospitalization for management of cSSSI. The primary objective is to compare infection-related hospital length of stay between participants treated with daptomycin and vancomycin. Secondary objectives were to compare participant reported outcomes (pain symptoms and Health Related Quality of Life), 30 day cSSSI-related hospital readmission rates, and cSSSI-related medical resource utilization and costs between participants treated with daptomycin and vancomycin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daptomycin | Experimental | 4 milligrams per kilogram (mg/kg) daptomycin administered intravenously (IV) once a day until end of antibiotic therapy for complicated skin and skin structure infections (cSSSI) or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion. |
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| Vancomycin | Active Comparator | Vancomycin was reconstituted per the manufacturer's instructions and was dosed per investigator's discretion and was administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occured first. Investigators treated participants according to their usual decision-making and discretion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daptomycin | Drug |
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| Vancomycin |
| Measure | Description | Time Frame |
|---|---|---|
| Infection-Related Hospital Length of Stay | Infection Related Hospital Length of Stay (IRLOS) is defined as the number of hours of hospitalization associated with antibiotic treatment of the complicated skin and skin structure infections (cSSSI) beginning at initiation of study-antibiotic administration and ending at discontinuation of all antibiotic therapy for cSSSI or at hospital discharge (whichever occurred first). This included continued hospitalization for treatment of adverse events resulting from use of the study antibiotic or subsequent antimicrobial therapy. The mean number of hours for each treatment group is presented. | Baseline (Day 0) through the End of Hospital Stay (up to Day 14) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to Hospital Discharge in Pain According to the Brief Pain Inventory-Short Form (BPI-SF) | Pain was measured as the amount of pain experienced "right now" by the participant using an 11-point numerical rating scale adapted from Brief Pain Inventory-Short Form (BPI-SF). Participants were asked to rate pain in his or her skin infection from 0 to 10, where 0 is no pain and 10 is pain as bad as he or she could imagine. Change from baseline to hospital discharge is presented; a negative value represents a decrease in pain. |
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Inclusion Criteria:
≥18 years of age
Primary reason for hospitalization is skin and skin structure infection of a complicated nature (for example, cellulitis/erysipelas, major cutaneous abscess, or wound infection) that requires IV antibiotic treatment for an anticipated 3 to14 days and hospitalization for management
i. Pain; tenderness to palpation; ii. Elevated temperature (>37.5°Celsius [99.5° Farenheit] oral or >38° Celsius [100.2° Farenheit] rectal); iii. Elevated white blood count (WBC) >10,000/millimeters cubed (mm^3); iv. Swelling and/or induration; erythema; v. Purulent or seropurulent drainage or discharge
Physician determination that vancomycin or daptomycin would be the initial treatment of choice for the cSSSI under study (or meets institutional criteria for use of vancomycin or daptomycin)
Informed consent obtained and signed
Less than 24 hours post hospital admission
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cubist Pharmaceuticals Medical Monitor Medical Monitor | Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26547411 | Derived | Kauf TL, McKinnon P, Corey GR, Bedolla J, Riska PF, Sims M, Jauregui-Peredo L, Friedman B, Hoehns JD, Mercier RC, Garcia-Diaz J, Brenneman SK, Ng D, Lodise T. An open-label, pragmatic, randomized controlled clinical trial to evaluate the comparative effectiveness of daptomycin versus vancomycin for the treatment of complicated skin and skin structure infection. BMC Infect Dis. 2015 Nov 7;15:503. doi: 10.1186/s12879-015-1261-9. |
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One participant enrolled in the study but was lost to follow up prior to being randomized to either treatment arm (daptomycin or vancomycin). This participant did not receive study drug and was not included in further analysis. No further details are available for this participant.
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| ID | Title | Description |
|---|---|---|
| FG000 | Daptomycin | Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for complicated skin and skin structure infections (cSSSI) or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
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| Baseline (Day 0), End of Hospital Stay (up to Day 14) |
| Mean Change From Baseline to Hospital Discharge in Participant-reported Health-related Quality of Life (HRQoL) | Health-related quality of life (HRQoL) was measured using the EuroQol-5 Dimensions, 5 Level (EQ-5D-5L) multi-attribute questionnaire. The 5 dimensions measured were: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant's health state was expressed by a descriptive profile of a 5 digit number. The EQ-5D health states were converted into a single summary index (from 0 to 1, with 0 representing death, to 1 representing perfect health) by applying weights to each of the levels in each dimension. Change from baseline to hospital discharge is presented; positive values represent an increase in health utility. | Baseline (Day 0), End of Hospital Stay (up to Day 14) |
| Participant Global Impression of Improvement (PGI-I) at Hospital Discharge | PGI-I assessments of improvement were measured by asking participants: How is your skin infection today compared to how it was yesterday? Scores were calculated based on response to the single item, where 1 = improved a lot; 2 = improved moderately; 3 = improved a little; 4 = no change; 5 = worsened a little; 6 = worsened moderately; 7 = worsened a lot. Mean PGI-I scores are presented at hospital discharge; lower values represent greater improvement. | End of Hospital Stay (up to Day 14) |
| 30-day cSSSI-related Hospital Readmission Rates | Hospital readmission rates were defined as readmission to an inpatient hospital facility within 30 days of hospital discharge for management of cSSSI relapse or treatment of adverse events related to cSSSI treatment. It did not include all-cause readmissions (for completeness, all-cause readmissions are reported in the descriptive tables). Participants were asked if they had been readmitted to the hospital since their discharge and whether the admission was specifically for their skin infection. The number of participants who were re-hospitalized for skin infection or side effects due to skin infection medication within 30 days since the initial hospital discharge (Day 14) is presented. | End of Hospital Stay (up to Day 14) through 30 days post hospital discharge |
| cSSSI-related Medical Resource Utilization and Costs | Direct medical costs were based on utilization of health resources. Unit cost data were obtained from sources external to the trial and assigned to corresponding medical resource utilization observed within the trial to estimate costs of care. cSSSI-related costs were reported from a societal perspective, and further broken down into a health care system perspective. The health care system perspective includes hospital and outpatient costs. The societal perspective includes the health care system perspective plus participant and caregiver time loss from work and participant and caregiver out-of-pocket expenses. Total cost (including both total inpatient and total post-discharge costs) per participant is presented. | Baseline (Day 0) through 30 days post hospital discharge |
| Chula Vista |
| California |
| United States |
| Escondido | California | United States |
| La Mesa | California | United States |
| Oceanside | California | United States |
| Augusta | Georgia | United States |
| Decatur | Georgia | United States |
| Waterloo | Iowa | United States |
| Topeka | Kansas | United States |
| Louisville | Kentucky | United States |
| New Orleans | Louisiana | United States |
| Worcester | Massachusetts | United States |
| Detroit | Michigan | United States |
| Royal Oak | Michigan | United States |
| Minneapolis | Minnesota | United States |
| Las Vegas | Nevada | United States |
| Albany | New York | United States |
| East Meadow | New York | United States |
| Mineola | New York | United States |
| The Bronx | New York | United States |
| Winston-Salem | North Carolina | United States |
| Columbus | Ohio | United States |
| Toledo | Ohio | United States |
| Rapid City | South Dakota | United States |
| Austin | Texas | United States |
| Ponce | Puerto Rico |
| FG001 |
| Vancomycin |
Vancomycin was reconstituted per the manufacturer's instructions and was dosed per investigator's discretion and was administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occured first. Investigators treated participants according to their usual decision-making and discretion. |
| Received at Least 1 Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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Baseline analysis population is drawn from the subset of the entire sample of participants that received at least 1 dose of study drug and that had complete data for calculating the primary outcome, infection-related length of stay (IRLOS).
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| ID | Title | Description |
|---|---|---|
| BG000 | Daptomycin | Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion. |
| BG001 | Vancomycin | Vancomycin was reconstituted per the manufacturer's instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion. |
| BG002 | 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, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Infection-Related Hospital Length of Stay | Infection Related Hospital Length of Stay (IRLOS) is defined as the number of hours of hospitalization associated with antibiotic treatment of the complicated skin and skin structure infections (cSSSI) beginning at initiation of study-antibiotic administration and ending at discontinuation of all antibiotic therapy for cSSSI or at hospital discharge (whichever occurred first). This included continued hospitalization for treatment of adverse events resulting from use of the study antibiotic or subsequent antimicrobial therapy. The mean number of hours for each treatment group is presented. | The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS. As the end of the IRLOS depended upon the participant's course of treatment, no static set of items were answered to determine if a participant had complete data. | Posted | Mean | Standard Deviation | Hours | Baseline (Day 0) through the End of Hospital Stay (up to Day 14) |
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| Secondary | Mean Change From Baseline to Hospital Discharge in Pain According to the Brief Pain Inventory-Short Form (BPI-SF) | Pain was measured as the amount of pain experienced "right now" by the participant using an 11-point numerical rating scale adapted from Brief Pain Inventory-Short Form (BPI-SF). Participants were asked to rate pain in his or her skin infection from 0 to 10, where 0 is no pain and 10 is pain as bad as he or she could imagine. Change from baseline to hospital discharge is presented; a negative value represents a decrease in pain. | The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS. Participants also had evaluable BPI-SF data at baseline and at hospital discharge. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), End of Hospital Stay (up to Day 14) |
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| Secondary | Mean Change From Baseline to Hospital Discharge in Participant-reported Health-related Quality of Life (HRQoL) | Health-related quality of life (HRQoL) was measured using the EuroQol-5 Dimensions, 5 Level (EQ-5D-5L) multi-attribute questionnaire. The 5 dimensions measured were: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The participant's health state was expressed by a descriptive profile of a 5 digit number. The EQ-5D health states were converted into a single summary index (from 0 to 1, with 0 representing death, to 1 representing perfect health) by applying weights to each of the levels in each dimension. Change from baseline to hospital discharge is presented; positive values represent an increase in health utility. | The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS. Participants also had evaluable EQ-5D data at baseline and at hospital discharge. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Day 0), End of Hospital Stay (up to Day 14) |
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| Secondary | Participant Global Impression of Improvement (PGI-I) at Hospital Discharge | PGI-I assessments of improvement were measured by asking participants: How is your skin infection today compared to how it was yesterday? Scores were calculated based on response to the single item, where 1 = improved a lot; 2 = improved moderately; 3 = improved a little; 4 = no change; 5 = worsened a little; 6 = worsened moderately; 7 = worsened a lot. Mean PGI-I scores are presented at hospital discharge; lower values represent greater improvement. | The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS. Participants also had evaluable PGI-I data at hospital discharge. | Posted | Mean | Standard Deviation | units on a scale | End of Hospital Stay (up to Day 14) |
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| Secondary | 30-day cSSSI-related Hospital Readmission Rates | Hospital readmission rates were defined as readmission to an inpatient hospital facility within 30 days of hospital discharge for management of cSSSI relapse or treatment of adverse events related to cSSSI treatment. It did not include all-cause readmissions (for completeness, all-cause readmissions are reported in the descriptive tables). Participants were asked if they had been readmitted to the hospital since their discharge and whether the admission was specifically for their skin infection. The number of participants who were re-hospitalized for skin infection or side effects due to skin infection medication within 30 days since the initial hospital discharge (Day 14) is presented. | The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS. | Posted | Number | participants | End of Hospital Stay (up to Day 14) through 30 days post hospital discharge |
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| Secondary | cSSSI-related Medical Resource Utilization and Costs | Direct medical costs were based on utilization of health resources. Unit cost data were obtained from sources external to the trial and assigned to corresponding medical resource utilization observed within the trial to estimate costs of care. cSSSI-related costs were reported from a societal perspective, and further broken down into a health care system perspective. The health care system perspective includes hospital and outpatient costs. The societal perspective includes the health care system perspective plus participant and caregiver time loss from work and participant and caregiver out-of-pocket expenses. Total cost (including both total inpatient and total post-discharge costs) per participant is presented. | The primary analytic sample (subset of the entire sample) comprised participants receiving at least 1 dose of study drug with complete data to calculate the primary outcome, IRLOS. | Posted | Mean | Standard Deviation | dollars (United States) | Baseline (Day 0) through 30 days post hospital discharge |
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Only serious adverse events were collected for this study.
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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 | Daptomycin | Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion. | 15 | 118 | 0 | 0 | ||
| EG001 | Vancomycin | Vancomycin was reconstituted per the manufacturer's instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion. | 9 | 106 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Blood and lymphatic system disorders | Systematic Assessment |
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| cardiac arrest | Cardiac disorders | Systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | Systematic Assessment |
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| Lyme infection, Lyme disease | General disorders | Systematic Assessment |
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| Allergic reaction (dermatologic) | Immune system disorders | Systematic Assessment |
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| Osteomyelitis, Foot | Infections and infestations | Systematic Assessment |
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| Worsening infection to left hand due to non-compliance | Infections and infestations | Systematic Assessment |
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| Right prepatella bursitis with abscess, Bursitis infective | Infections and infestations | Systematic Assessment |
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| Acute Viral Syndrome | Infections and infestations | Systematic Assessment |
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| Bilat Lower Extrem Cellulitis, Cellulitis of legs | Infections and infestations | Systematic Assessment |
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| Chest Wall infection status post right breast implant removal | Infections and infestations | Systematic Assessment |
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| Clinical worsening of right below knee stump infection | Infections and infestations | Systematic Assessment |
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| Left hallux osteomyelitis | Infections and infestations | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | Systematic Assessment |
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| Osteomyelitis with septic arthritis | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Right Leg Cellulitis | Infections and infestations | Systematic Assessment |
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| Seizure | Nervous system disorders | Systematic Assessment |
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| altered mental status | Psychiatric disorders | Systematic Assessment |
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| respiratory failure | Renal and urinary disorders | Systematic Assessment |
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| Renal insufficiency | Renal and urinary disorders | Systematic Assessment |
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| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| red man syndrome | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| social admission for reassignment of nursing home | Social circumstances | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Research | Cubist Pharmaceuticals | 1.781.860.8660 |
| ID | Term |
|---|---|
| D013207 | Staphylococcal Skin Infections |
| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D017192 | Skin Diseases, Bacterial |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017576 | Daptomycin |
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| Title | Measurements |
|---|---|
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| 40-49 Years Old |
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| 50-59 Years Old |
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| 60-69 Years Old |
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| 70+ Years Old |
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| Male |
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Vancomycin was reconstituted per the manufacturer's instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
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