Daptomycin in the Treatment of Subjects With Infective Endocarditis or Bacteremia Due to S. Aureus
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|ClinicalTrials.gov Identifier: NCT00093067|
Recruitment Status : Completed
First Posted : October 1, 2004
Last Update Posted : February 13, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Bacterial Endocarditis Bacteremia||Drug: daptomycin||Phase 3|
Even with prompt treatment, Staphylococcus aureus Infective Endocarditis (IE) continues to be associated with significant morbidity and mortality indicating a need for new therapeutic approaches. In vitro, daptomycin is rapidly bactericidal, with concentration-dependent killing, and MIC90 of 0.5 microgram/ml for S. aureus; in clinical studies, daptomycin appears to be well tolerated and can be administered once every 24 hours by i.v. infusion. These characteristics suggest it should be clinically and microbiologically effective in the treatment of serious S. aureus infections, including IE and bacteremia
Comparison: standard of care (Vancomycin or Semi-synthetic Penicillin with adjunct gentamicin)
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Multicenter, Randomized, Open-Label, Comparative Study to Assess the Safety and Efficacy of Daptomycin Compared to Conventional Therapy In the Treatment of Subjects With Infective Endocarditis or Bacteremia Due to Staph Aureus|
|Study Start Date :||March 2002|
|Actual Primary Completion Date :||November 2004|
|Actual Study Completion Date :||February 2005|
- To demonstrate that daptomycin is not inferior to comparator in the treatment of S. aureus bacteremia and IE as assessed by the Independent External Adjudication Committee (IEAC) Outcome at Test of Cure (TOC) in the Intention-to-Treat (ITT) population.
- To compare clinical success rates between daptomycin and comparator in the treatment of S. aureus bacteremia and IE as assessed by the IEAC Outcome at End of Treatment (EOT) in the ITT population.
- To compare clinical success rates between daptomycin and comparator in the treatment of S. aureus bacteremia and IE as assessed by the IEAC Outcome at EOT and TOC in the Per Protocol (PP) population.
- To compare clinical success rates between daptomycin and comparator in the treatment of S. aureus bacteremia and IE as assessed by the IEAC Outcome for each of the diagnoses defined by the IEAC at EOT in the ITT population.
- To compare clinical success rates between daptomycin and comparator in the treatment of S. aureus bacteremia and IE as assessed by the IEAC Outcome for each of the diagnoses defined by the Investigator at EOT in the ITT population.
- To compare microbiologic eradication rates between daptomycin and comparator.
- To demonstrate that survival rates are similar between daptomycin and comparator in the ITT population.
- To evaluate the safety of daptomycin as compared to comparator in the safety population.
- To assess the pharmacokinetics of daptomycin.
- To compare the pharmacoeconomic impact of daptomycin with that of comparator.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Documented S. aureus bacteremia within 2 calendar days of the first dose of study medication
- Subjects with a creatinine clearance of less than 30 ml/min
- Subjects with pneumonia
- Pregnant, nursing, or lactating
- Documented history of allergy or intolerance to penicillin or vancomycin
- Subjects with osteomyelitis
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Cubist Pharmaceuticals LLC|
|Other Study ID Numbers:||
DAP-IE-01-02 ( Other Identifier: Cubist )
|First Posted:||October 1, 2004 Key Record Dates|
|Last Update Posted:||February 13, 2017|
|Last Verified:||February 2017|
Gram-positive bacterial infections
Bacterial Infections and Mycoses
Systemic Inflammatory Response Syndrome