NCT00426933

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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 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

Conditions

• Soft Tissue Infections

Interventions

Type	Name	Description
DRUG	Daptomycin
DRUG	Vancomycin

Timeline

• Start date: 2007-01-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2007-01-25
• Last updated: 2010-09-14

Locations

1 site across 1 country: United States