Infective Endocarditis Clinical Trial
Official title:
A Phase 2 Multicenter, Randomized, Double-blinded, Study to Describe the Safety, Efficacy, and Pharmacokinetics of Daptomycin 10 mg/kg/Day and Vancomycin for the Treatment of Methicillin-resistant Staphylococcus Aureus Bacteremia
The overall goals of this study are to compare the safety and efficacy of daptomycin monotherapy 10 mg/kg/day and vancomycin monotherapy dosed to achieve vancomycin trough levels of 15 to 20 μg/mL for the treatment of methicillin-resistant S. aureus bacteremia (MRSA), including right-sided infective endocarditis (RIE).
Patients who meet all inclusion criteria and exhibit none of the exclusion criterial will be
randomized to one of two treatment arms:
1. daptomycin Intravenously (IV) 10 mg/kg every 24 hours
2. vancomycin IV dosed to maintain trough levels of 15 to 20 μg/mL.
The suggested duration of therapy with daptomycin or vancomycin will be 28 days (or up to 42
days if clinically indicated). Dose adjustments for both drugs will be made by an unblinded
pharmacist at each site. To minimize the duration with which patients are treated with
antibacterial agents effective against S. aureus prior to enrollment, patients with suspected
MRSA bacteremia will be enrolled pending definitive culture results. Suspected MRSA
bacteremia will be defined clinically or as initial blood cultures that grow Gram-positive
cocci and that were obtained from a patient at increased risk for methicillin-resistant S.
aureus infections. However, only patients with confirmed MRSA bacteremia or right-sided
infective endocarditis will remain in the study and be evaluated for efficacy. During
treatment, regular assessments will be performed. An End-of Therapy (EOT) will be performed
1-3 days after stopping therapy or upon Early Termination (ET). All patients will have a post
therapy visit for Test of Cure (TOC) performed 35-49 days following last dose of study drug.
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