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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 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)


Sponsor: Cubist Pharmaceuticals LLC

Current Primary Outcome: 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.

Original Primary Outcome:

Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

Information By: Cubist Pharmaceuticals LLC

Dates:
Date Received: September 30, 2004
Date Started: March 2002
Date Completion:
Last Updated: February 9, 2017
Last Verified: February 2017