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

Bacteremia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00093067
• Other study ID #: 3009-007
• Secondary ID: DAP-IE-01-02
• Status: Completed
• Phase: Phase 3
• First received: September 30, 2004
• Last updated: February 9, 2017
• Start date: March 2002
• Est. completion date: February 2005

Study information

• Verified date: February 2017
• Source: Cubist Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2005
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacteremia
• Bacterial Endocarditis
• Endocarditis
• Endocarditis, Bacterial

Intervention

Drug:
• daptomycin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cubist Pharmaceuticals LLC

References & Publications (1)

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, Fätkenheuer G, Gareca M, Rehm — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	To compare microbiologic eradication rates between daptomycin and comparator.
Secondary	To demonstrate that survival rates are similar between daptomycin and comparator in the ITT population.
Secondary	To evaluate the safety of daptomycin as compared to comparator in the safety population.
Secondary	To assess the pharmacokinetics of daptomycin.
Secondary	To compare the pharmacoeconomic impact of daptomycin with that of comparator.