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Sponsored by: |
Cubist Pharmaceuticals |
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Information provided by: | Cubist Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00638157 |
multicenter, randomized, double blind study to describe the safety and efficacy of daptomycin (6 mg/kg q24h) with and without concomitant initial gentamicin combination therapy in the treatment of SAIE
Condition | Intervention | Phase |
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Infective Endocarditis |
Drug: daptomycin Drug: daptomycin and gentamicin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 4 Multicenter, Randomized, Double Blind Study to Describe the Efficacy and Safety of Cubicin® (Daptomycin for Injection) With and Without Initial Gentamicin Combination Therapy in the Treatment of S. Aureus Infective Endocarditis |
Estimated Enrollment: | 60 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
daptomycin (6 mg/kg q24h)
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Drug: daptomycin
6 mg/kg q24h
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2: Experimental
daptomycin (6 mg/kg q24h) with concomitant initial gentamicin combination therapy
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Drug: daptomycin and gentamicin
daptomycin 6 mg/kg q24h plus initial i.v. gentamicin
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Patients will be randomized to either of the following two treatment arms:
Patients who meet all the inclusion criteria and exhibit none of the exclusion criteria may be enrolled. IVDU patients may be randomized and study drug begun on the basis of two separate peripheral blood cultures positive for S. aureus obtained within 96 hours prior to the first dose of study drug.
The recommended minimum duration of treatment for daptomycin will be 28 days. The duration of treatment for gentamicin will be 3 days.
During study treatment, regular assessments (including weekly safety laboratory testing including CPK) will be performed. An End-of-Therapy (EOT) evaluation will be performed on the day of or 1-2 days after completion of daptomycin study drug or upon early termination (ET). All patients will have a post-therapy visit for Test of Cure (TOC)/Safety performed 21-28 days following the last dose of daptomycin study drug.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
High likelihood of LIE as indicated by:
Note: Any patient enrolled in the study that is subsequently found to have LIE may be continued in the trial if determined to be clinically improving by the Investigator.
Contact: Katharin Blackerby | (781) 860-8311 | katharin.blackerby@cubist.com |
United States, Colorado | |
Denver Health Medical Center | Recruiting |
Denver, Colorado, United States, 80204 | |
Principal Investigator: Connie Price, MD | |
United States, Michigan | |
Henry Ford Health System | Recruiting |
Detroit, Michigan, United States, 48202 | |
Principal Investigator: Marcus Zervos, MD | |
Wayne State University | Recruiting |
Detroit, Michigan, United States, 48201 | |
Principal Investigator: Donald Levine, MD | |
United States, Pennsylvania | |
Temple University School of Medicine | Recruiting |
Philadelphia, Pennsylvania, United States, 19140 | |
Principal Investigator: Byungse Suh, MD |
Study Director: | Peter Pertel, M.D. | Cubist Pharmaceuticals |
Responsible Party: | Cubist Pharmaceuticals ( Katharin Blackerby ) |
Study ID Numbers: | DAP-4IE-06-03 |
Study First Received: | March 12, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00638157 |
Health Authority: | United States: Food and Drug Administration |
Gram-positive bacterial infections Staph Aureus endocarditis bacteremia MRSA |
Bacterial Infections Heart Diseases Bacteremia Bacterial endocarditis Endocarditis Daptomycin Staphylococcal Infections |
Gram-Positive Bacterial Infections Endocarditis, Bacterial Infective endocarditis Endocarditis, infective Gentamicins Cardiovascular Infections |
Protein Synthesis Inhibitors Anti-Infective Agents Anti-Bacterial Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Enzyme Inhibitors Cardiovascular Diseases Infection Pharmacologic Actions |