Phase 2 Study of Safety, Efficacy, and Pharmacokinetics of Higher Doses of Daptomycin and Vancomycin in MRSA Bacteremia

Stopped early · Phase 2

Conditions studied: Endocarditis, Bacterial, Infective Endocarditis

In brief

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).

Key facts

Study ID

NCT00695903

Run by

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

People needed

38

Starts

2008-09-17

Expected to finish

2010-10-01

Last updated by the study team

2018-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent has been obtained;
• ≥18 years of age;
• Suspected MRSA bacteremia determined by clinical judgment or 2 sets of positive blood cultures;
• Increased risk for an MRSA infection

You may not qualify if…

• Received >48 hours of vancomycin therapy in the 7 days prior to enrollment;
• Received any systemic antibacterial agents potentially effective against MRSA in the 7 days prior to enrollment;
• Anticipated requirement of antibiotics potentially effective against MRSA;
• High likelihood of left-sided infective endocarditis (LIE);
• Known/suspected polymicrobial bacteremia or infection including Gram-negative infections;
• Known pneumonia, osteomyelitis, or meningitis;
• Intravascular foreign material unless material intended removed within 3 days;
• Prosthetic heart valve;
• Cardiac decompensation, valve damage, or both such that high likelihood of valve replacement surgery within first 3 days of study drug treatment;
• Moribund clinical condition such that death likely within first 3 days of study drug treatment;
• Shock or hypotension or oliguria unresponsive to fluids after 4 hours;
• Received investigational drug within 30 days of study entry
• Received statins or other therapy with associated with rhabdomyolysis within 2 days of study entry;
• History of significant allergy or intolerance to vancomycin or daptomycin
• Infecting pathogen with confirmed reduced susceptibility to vancomycin;
• Infecting pathogen with confirmed reduced susceptibility to daptomycin
• Creatinine clearance <30 mL/min (Cockcroft-Gault equation actual body weight)
• Serum creatine phosphokinase (CPK) ≥500 U/L
• Alanine transaminase (ALT) or aspartate aminotransferase (AST) >5 X ULN;
• Total bilirubin ≥3.0 mg/dL;
• Severe neutropenia or expected development severe neutropenia during study;
• Known or suspected HIV infection with a CD4+ T-cell count <200/μL;
• Unlikely to comply with study procedures or return for evaluations;
• Body Mass Index (BMI) ≥40 kg/m2;
• Pregnant or nursing;

Where it is running

• East Carolina University — Greenville, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.