Phase 4 Efficacy and Safety Study of Cubicin® With and Without Combination Therapy in S. Aureus I… (NCT00638157) | Clinical Trial Compass
TerminatedPhase 4
Phase 4 Efficacy and Safety Study of Cubicin® With and Without Combination Therapy in S. Aureus Infective Endocarditis (SAIE)
Stopped: commitment completed
United States24 participantsStarted 2009-02-13
Plain-language summary
multicenter, randomized, double blind study to describe the safety and efficacy of daptomycin (6 mg/kg q24h) with and without concomitant initial gentamicin combination therapy in the treatment of SAIE
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Written informed consent has been obtained;
✓. Male or female ≥18 years of age;
✓. IVDU (as confirmed by history of drug abuse within the past 3 months or recent needle track marks);
✓. Definite or possible IE according to the modified Duke Criteria (see Appendix A); \[17 \];
✓. Two blood cultures positive for S. aureus obtained within 96 hours prior to first dose of study medication acquired by fresh venipuncture using aseptic technique and analyzed at the local laboratory (see Appendix B).
Exclusion criteria
✕. Intravascular foreign material in place at the time that the positive blood culture was drawn (e.g., intracardiac pacemaker wires, percutaneous or implanted venous catheters, vascular grafts), (exception: vascular stents that have been in place for \>6 months or permanent pacemaker wires attached via epicardial leads are allowed);
✕. High likelihood of LIE as indicated by:
✕. Prior diagnosis of predisposing left-sided valvular pathology (e.g., rheumatic heart disease, bicuspid aortic valve); or
✕. Findings on screening examination of left-sided valvular pathology (e.g., diastolic murmur of aortic insufficiency); or
✕. Findings on screening examination of major systemic emboli to visceral organs (e.g. cerebral or splenic infarct). Patients may be included if their only findings are consistent with microvascular phenomena due to immune complexes (e.g., splinter hemorrhages, conjunctival petechiae, Roth's spots, Osler's nodes, Janeway's lesions, microhematuria).
What they're measuring
1
Summary of Clinically Significant Increases in Serum Creatinine by Visit
Timeframe: Baseline, EOT Visit, TOC
Trial details
NCT IDNCT00638157
SponsorCubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)