Phase 2 Safety and Efficacy Study of Daptomycin in Complicated Skin and Skin Structure Infections
Completed · Phase 2
Conditions studied: Soft Tissue Infections
In brief
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.
Key facts
- Study ID
- NCT00426933
- Run by
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- People needed
- 100
- Starts
- 2007-01-01
- Expected to finish
- 2007-09-01
- Last updated by the study team
- 2010-09-14
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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:
- Pain;
- Tenderness to palpation;
- Elevated Temperature;
- Elevated White blood count;
- Swelling and/or induration;
- Erythema (>1 cm beyond edge of wound or abscess);
- Pus formation;
- Creatinine clearance of ≥50 mL/min.
You may not qualify if…
- 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;
- Myositis with or without skin and skin structure infections;
- Hemodialysis or peritoneal dialysis;
- BMI ≥40 kg/m2;
- Previous antibiotics exceeding 24 hours within the 48 hours prior to the first dose of study drug
- Patients admitted for rhabdomyolysis including drug overdose
- Neutropenic patients with absolute neutrophil count ≤500 cells/mm3
- Known HIV-infected patients with CD4 count ≤200 cells/ mm3;
- Baseline CPK values ≥2 X ULN (upper limit of normal);
- Has received an investigational drug within 30 days of study entry;
- Known to be allergic or intolerant to study medications;
- unlikely to comply with study procedures
- Is expected to receive HMG CoA Reductase Inhibitors from enrollment through End of Treatment
Where it is running
- Idaho Falls Infectious Diseases, PLLC — Idaho Falls, Idaho, United States
Full record on ClinicalTrials.gov
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