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Sponsored by: |
Cubist Pharmaceuticals |
Information provided by: | Cubist Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00428844 |
This is a research study designed to look at the efficacy and safety of daptomycin given at a dose of 6 mg/kg or 8 mg/kg in subjects being treated for prosthetic hip or knee infections caused by methicillin-resistant Staphylococcus aureus (MRSA) or coagulase-negative staphylococci (CoNS). These two types of bacteria are among the most common types of bacteria causing infections of prosthetic joints.
Condition | Intervention | Phase |
Osteomyelitis |
Drug: daptomycin Drug: vancomycin |
Phase II |
ChemIDplus related topics: | Vancomycin Daptomycin Vancomycin hydrochloride Methicillin Methicillin sodium Teicoplanin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2 Randomized Study Investigating the Safety, Efficacy and Pharmacokinetics of Daptomycin 6 mg/kg and 8 mg/kg Versus Comparator (Vancomycin or Teicoplanin) in the Treatment of Subjects Undergoing Surgical Standard of Care for Osteomyelitis Associated With an Infected Prosthetic Hip or Knee Joint Caused by Methicillin-Resistant Staphylococcus Aureus and/or Coagulase-Negative Staphylococci |
Estimated Enrollment: | 72 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Daptomycin 6 mg/kg
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Drug: daptomycin
6 mg/kg
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2: Experimental
Daptomycin 8 mg/kg
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Drug: daptomycin
8 mg/kg
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3: Active Comparator
vancomycin 1 gm
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Drug: vancomycin
1 gm
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Marie Hippolyte | 781-860-8122 | marie.hippolyte@cubist.com |
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Show 22 Study Locations |
Cubist Pharmaceuticals |
Principal Investigator: | Margarita Cancio, MD | Infectious Disease Association of Tampa Bay |
Responsible Party: | Cubist Pharmaceuticals ( Marie Hippolyte, Senior Clinical Trial Manager ) |
Study ID Numbers: | DAP-OST-06-02 |
First Received: | January 26, 2007 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00428844 |
Health Authority: | United States: Food and Drug Administration |
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