Phase 2 Safety and Efficacy Study of Daptomycin in Complicated Skin and Skin Structure Infections

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The main criteria for evaluation will be: Efficacy Safety Microbiologic eradication

Official Title
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Phase 2 Multicenter Randomized Semi-Single Blind Study to Compare Efficacy and Safety of High-dose Short Duration Daptomycin With Conventional Therapy in Complicated Skin and Skin Structure Infections Due to Gram-positive Bacteria

Conditions
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Soft Tissue Infections

Intervention / Treatment
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* Drug: Daptomycin
* Drug: Vancomycin


Participation Criteria
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Eligibility Criteria
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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: 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 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; 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Daptomycin|nan|
|Drug: Vancomycin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response Rate at TOC |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference between clinical response rates at EOT |  |  | 
| microbiological eradication rates |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cSSSI, MRSA