Status:
COMPLETED
Phase 2 Safety and Efficacy Study of Daptomycin in Complicated Skin and Skin Structure Infections
Lead Sponsor:
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Soft Tissue Infections
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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 pat...
Detailed Description
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 pat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00426933
Start Date
January 1 2007
End Date
September 1 2007
Last Update
September 14 2010
Active Locations (1)
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1
Idaho Falls Infectious Diseases, PLLC
Idaho Falls, Idaho, United States, 83404