Conditions: Infective Endocarditis
Keywords: Gram-positive bacterial infections Staph Aureus endocarditis bacteremia methicillin-resistant Staphylococcus aureus (MRSA)
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 24
Healthy volunteers: no

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 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.

Arms:
arm 1: daptomycin 6 mg/kg q24h for treatment of right-sided infective endocarditis arm 2: daptomycin 6 mg/kg q24h with concomitant initial gentamicin dosed for the first 2 days of therapy for the treatment of right-sided infective endocarditis

Interventions: intervention 1: daptomycin intervention 2: daptomycin and gentamicin
Intervention descriptions: intervention 1: Intravenous (i.v.) 6 mg/kg q24h intervention 2: i.v. daptomycin 6 mg/kg q24h plus initial i.v. gentamicin

Protocol document: