NCT00638157

Phase 4 Efficacy and Safety Study of Cubicin® With and Without Combination Therapy in S. Aureus Infective Endocarditis (SAIE)

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 Treatment of S. Aureus Infective Endocarditis

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Infective Endocarditis

Interventions

Type	Name	Description
DRUG	daptomycin	Intravenous (i.v.) 6 mg/kg q24h
DRUG	daptomycin and gentamicin	i.v. daptomycin 6 mg/kg q24h plus initial i.v. gentamicin

Timeline

• Start date: 2009-02-13
• Primary completion: 2011-11-09
• Completion: 2011-11-09
• First posted: 2008-03-18
• Last updated: 2021-02-02
• Results posted: 2013-05-22

Locations

4 sites across 1 country: United States