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

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:

MedlinePlus related topics: Bacterial Infections Endocarditis Staphylococcal Infections

Drug Information available for: Staphylococcus aureus Daptomycin

U.S. FDA Resources

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

No Contacts or Locations Provided

More Information

Publications:

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bhavnani SM, Rubino CM, Ambrose PG, Drusano GL. Daptomycin exposure and the probability of elevations in the creatine phosphokinase level: data from a randomized trial of patients with bacteremia and endocarditis. Clin Infect Dis. 2010 Jun 15;50(12):1568-74.

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 May 21, 2013