Daptomycin in the Treatment of Subjects With Infective Endocarditis or Bacteremia Due to S. Aureus

This study has been completed.
Sponsor:
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00093067
First received: September 30, 2004
Last updated: February 7, 2007
Last verified: December 2006
  Purpose

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).


Condition Intervention Phase
Bacterial Endocarditis
Bacteremia
Drug: daptomycin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Cubist Pharmaceuticals:

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
Detailed Description:

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 g/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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00093067     History of Changes
Other Study ID Numbers: DAP-IE-01-02
Study First Received: September 30, 2004
Last Updated: February 7, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Cubist Pharmaceuticals:
Gram-positive bacterial infections
Staph Aureus
endocarditis
bacteremia
Cubist

Additional relevant MeSH terms:
Bacteremia
Endocarditis
Endocarditis, Bacterial
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Cardiovascular Infections
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014