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Completed

NCT Number: NCT00093067

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

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).

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Key information

Conditions

Bacterial Endocarditis Bacteremia Bacterial Infections Bacterial Infections and Mycoses Cardiovascular Diseases Cardiovascular Infections Endocarditis Endocarditis, Bacterial Gram-Positive Bacterial Infections Heart Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Staphylococcal Infections Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

daptomycin

Drug

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. To compare microbiologic eradication rates between daptomycin and comparator.

  6. To demonstrate that survival rates are similar between daptomycin and comparator in the ITT population.

  7. To evaluate the safety of daptomycin as compared to comparator in the safety population.

  8. To assess the pharmacokinetics of daptomycin.

  9. To compare the pharmacoeconomic impact of daptomycin with that of comparator.

Sponsors and collaborators

Lead sponsor

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2004
Study completion
2005
First posted
Oct 1, 2004
Registry last updated
Feb 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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