Clinical Trial: Phase 4 Efficacy and Safety Study of Cubicin® With and Without Combination Therapy in S. Aureus Infective Endocarditis (SAIE)
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase 4 Multicenter, Randomized, Double Blind Study to Describe the Efficacy and Safety of Cubicin® (Daptomycin for Injection) With and Without Initial Gentamicin Combination Therapy in the Tre
Brief 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
Detailed Summary:
Patients will be randomized to either of the following two treatment arms:
- Arm 1: daptomycin
- Arm 2: daptomycin with initial i.v. gentamicin
Patients who meet all the inclusion criteria and exhibit none of the exclusion criteria may be enrolled. Intravenous drug user (IVDU) patients may be randomized and study drug begun on the basis of two separate peripheral blood cultures positive for S. aureus obtained within 96 hours prior to the first dose of study drug.
The recommended minimum duration of treatment for daptomycin will be 28 days. The duration of treatment for gentamicin will be 3 days.
During study treatment, regular assessments (including weekly safety laboratory testing including CPK) will be performed. An End-of-Therapy (EOT) evaluation will be performed on the day of or 1-2 days after completion of daptomycin study drug or upon early termination (ET). All patients will have a post-therapy visit for Test of Cure (TOC)/Safety performed 21-28 days following the last dose of daptomycin study drug.
Sponsor: Cubist Pharmaceuticals LLC
Current Primary Outcome: Summary of Clinically Significant Increases in Serum Creatinine by Visit [ Time Frame: Baseline, EOT Visit, TOC ]
Original Primary Outcome: incidence of adverse events [ Time Frame: 4 Weeks ]
Current Secondary Outcome: Summary of the Investigator's Assessment of Clinical Response at the TOC Visit [ Time Frame: TOC Visit ]
Original Secondary Outcome: Investigator's assessment of clinical response at TOC [ Time Frame: 4 Weeks ]
Information By: Cubist Pharmaceuticals LLC
Dates:
Date Received: March 12, 2008
Date Started: March 2008
Date Completion:
Last Updated: January 5, 2016
Last Verified: January 2016