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The purpose of this study is to compare the safety and efficacy of daptomycin, an antibiotic, to standard therapy in subjects who have infective endocarditis or bacteremia due to Staphylococcus aureus (S. aureus).
Bacterial Endocarditis
Bacteremia
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Drug: daptomycin
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Phase III
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U.S. FDA Resources
| Study Type: |
Interventional |
| Study Design: |
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
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| 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 |
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Study Start Date: |
August 2002 |
| Estimated Study Completion Date: |
February 2005 |
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 %uF06Dg/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)
| Ages Eligible for Study: |
18 Years and older |
| Genders Eligible for Study: |
Both |
| Accepts Healthy Volunteers: |
No |
Inclusion Criteria:
- Documented S. aureus bacteremia within 2 calendar days of the first dose of study medication
Exclusion Criteria:
- 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
No Contacts or Locations Provided
Publications of Results:
Fowler VG Jr, Boucher HW, Corey GR, Abrutyn E, Karchmer AW, Rupp ME, Levine DP, Chambers HF, Tally FP, Vigliani GA, Cabell CH, Link AS, DeMeyer I, Filler SG, Zervos M, Cook P, Parsonnet J, Bernstein JM, Price CS, Forrest GN, Fatkenheuer G, Gareca M, Rehm SJ, Brodt HR, Tice A, Cosgrove SE; S. aureus Endocarditis and Bacteremia Study Group. Daptomycin versus standard therapy for bacteremia and endocarditis caused by Staphylococcus aureus. N Engl J Med. 2006 Aug 17;355(7):653-65.
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| Study ID Numbers: |
DAP-IE-01-02 |
| First Received: |
September 30, 2004 |
| Last Updated: |
February 7, 2007 |
| ClinicalTrials.gov Identifier: |
NCT00093067 |
| Health Authority: |
United States: Food and Drug Administration |
Keywords provided by Cubist Pharmaceuticals:
| Gram-positive bacterial infections |
| Staph Aureus |
| endocarditis |
| bacteremia |
| Cubist | | Study placed in the following topic categories:
| Bacterial Infections |
| Systemic Inflammatory Response Syndrome |
| Heart Diseases |
| Bacteremia |
| Bacterial endocarditis |
| Endocarditis |
| Inflammation | |
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| Daptomycin |
| Mycoses |
| Gram-Positive Bacterial Infections |
| Sepsis |
| Endocarditis, Bacterial |
| Infective endocarditis |
| Endocarditis, infective | | Additional relevant MeSH terms:
| Bacteremia |
| Anti-Infective Agents |
| Anti-Bacterial Agents |
| Pathologic Processes |
| Bacterial Infections and Mycoses |
| Therapeutic Uses | |
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| Cardiovascular Diseases |
| Cardiovascular Infections |
| Infection |
| Pharmacologic Actions |
| Pathological Conditions, Signs and Symptoms | |
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