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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Cubist Pharmaceuticals |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00467272 |
Primary Objective:
-Evaluate the clinical efficacy and safety of Daptomycin given for treatment of catheter-related bloodstream infections (CRBSI) due to gram positive bacteremia in the context of standard of care antimicrobial therapy consisting mainly of Vancomycin with or without initial treatment with beta lactam antibiotics.
Condition | Intervention | Phase |
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Bloodstream Infection |
Drug: Daptomycin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II, Open-Label Study to Evaluate the Safety and Efficacy of Daptomycin in the Treatment of Catheter-Related Gram Positive Bloodstream Infections |
Estimated Enrollment: | 40 |
Study Start Date: | March 2007 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Daptomycin
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Drug: Daptomycin
6 mg/kg IV every 24 hours for at least 7-14 days, depending on the type of bacteria.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
U.T.M.D. Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Issam Raad, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Issam Raad, MD/Professor ) |
Study ID Numbers: | 2006-0958 |
Study First Received: | April 26, 2007 |
Last Updated: | November 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00467272 |
Health Authority: | United States: Institutional Review Board |
Catheter-Related Bloodstream Infections Bloodstream Infection Daptomycin Cubicin CRBSI |
Daptomycin |
Anti-Infective Agents Anti-Bacterial Agents Communicable Diseases |
Therapeutic Uses Infection Pharmacologic Actions |