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

Tracking Information
First Received Date ^ICMJE	September 30, 2004
Last Updated Date	February 7, 2007
Start Date ^ICMJE	August 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: August 17, 2005)	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 Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00093067 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 17, 2005)	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 Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Daptomycin in the Treatment of Subjects With Infective Endocarditis or Bacteremia Due to S. Aureus
Official Title ^ICMJE	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
Brief 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).
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)
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Bacterial Endocarditis Bacteremia
Intervention ^ICMJE	Drug: daptomycin
Study Arms / Comparison Groups
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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date	February 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00093067
Responsible Party
Study ID Numbers ^ICMJE	DAP-IE-01-02
Study Sponsor ^ICMJE	Cubist Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Cubist Pharmaceuticals
Verification Date	December 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP