A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections (NCT01283581) | Clinical Trial Compass
CompletedPhase 2
A Study to Assess Objective Endpoint Measurements of Response in Bacterial Skin Infections
United States256 participantsStarted 2011-01
Plain-language summary
The purpose of this study is to compare clinical response to the measurement techniques of several objective measures of clinical efficacy for use in future ABSSSI (Acute Bacterial Skin and Skin Structure Infection) clinical trials
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Adult (≥ 18 years of age) men or women
* Sexually active women and men with partners of childbearing potential must agree to use an acceptable form of contraception as determined by the investigator during participation in the study and for 30 days after the final dose of study drug
* Female partners of male subjects should also use an additional reliable method of contraception during study and for 30 days after the final dose of study drug
* Subjects must have a diagnosis of ABSSSI - one or more of the following 4 infection types: cellulitis/erysipelas, wound infection, major cutaneous abscess, or burn infection
* Subjects must have lymph node enlargement due to the present infection or at least one of the following symptoms of systemic infection: fever ≥ 38°C, lymphangitis, WBC (white blood cell) count ≥ 15,000 cells/μL, elevated C-reactive protein (\> 5.0mg/L)
* In the opinion of the investigator, the subject must require and be a suitable candidate for IV antibiotic therapy
Exclusion Criteria:
* A medical history of significant hypersensitivity or allergic reaction to quinolones, linezolid, vancomycin, or vancomycin derivatives
* Women who are pregnant or lactating
* Any chronic or underlying skin condition at the site of infection that may complicate the assessment of response
* Subjects with any of the following: infection involving prosthetic materials or foreign bodies, infection associated with a human or animal bite, osteomyelitis, decubitu…
What they're measuring
1
Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up