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Sponsored by: |
Cubist Pharmaceuticals |
Information provided by: | Cubist Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00426933 |
This is a 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.
Condition | Intervention | Phase |
Soft Tissue Infections |
Drug: Daptomycin Drug: Vancomycin |
Phase II |
ChemIDplus related topics: | Vancomycin Daptomycin Vancomycin hydrochloride |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 90 |
Study Start Date: | January 2007 |
Study Completion Date: | September 2007 |
This is a 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:
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
At least three clinical signs and symptoms associated with the cSSSI:
Exclusion Criteria:
United States, Idaho | |||||
Idaho Falls Infectious Diseases, PLLC | |||||
Idaho Falls, Idaho, United States, 83404 |
Cubist Pharmaceuticals |
Principal Investigator: | Richard Nathan, D.O. | Idaho Falls Infectious Diseases, PLLC |
Study ID Numbers: | DAP-HDSD-06-01 |
First Received: | January 23, 2007 |
Last Updated: | October 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00426933 |
Health Authority: | United States: Food and Drug Administration |
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