Phase 2 Safety and Efficacy Study of Daptomycin in Complicated Skin and Skin Structure Infections (NCT00426933) | Clinical Trial Compass
CompletedPhase 2
Phase 2 Safety and Efficacy Study of Daptomycin in Complicated Skin and Skin Structure Infections
United States100 participantsStarted 2007-01
Plain-language summary
multicenter, randomized (1:1), semi-single blind study comparing the safety and efficacy of HDSD daptomycin (10 mg/kg q24h for 4 days) with that of comparator (vancomycin +/- SSP for 7-14 days) in patients with cSSSI due to Gram-positive bacteria. Patients will be randomized on a 1:1 basis to receive either daptomycin 10 mg/kg i.v. q24h for 4 days or vancomycin 1 g. q12h for up to 14 days.
Who can participate
Age range18 Years – 85 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Informed consent obtained
✓. Male or female ≥18 years of age
✓. If female of childbearing potential, willing to practice reliable birth control measures and documented negative pregnancy test
✓. Skin and skin structure infections of a complicated nature that require intravenous antibiotic treatment
✓. Gram-positive infecting pathogen
✓. Physician determination that vancomycin would be the initial treatment of choice
✓. At least three clinical signs and symptoms associated with the cSSSI:
✓. Creatinine clearance of ≥50 mL/min.
Exclusion criteria
✕. MSSA
✕. Known or suspected bacteremia, osteomyelitis, or endocarditis
✕. Primary study infection of an uncomplicated nature such as furuncles, simple abscesses, cellulitis not requiring i.v., perirectal abscess, hidradenitis suppurativa, third degree burn infections or other minor infections;
✕. Conditions where required surgery (in and of itself) constitutes curative treatment of the infection (e.g., amputation);
✕. Necrotizing infections or concomitant gangrene;
What they're measuring
1
Clinical Response Rate at TOC
Trial details
NCT IDNCT00426933
SponsorCubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)