Status:
TERMINATED
Phase 2 Study of Safety, Efficacy, and Pharmacokinetics of Higher Doses of Daptomycin and Vancomycin in MRSA Bacteremia
Lead Sponsor:
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Endocarditis, Bacterial
Infective Endocarditis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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. vanco...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- 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
- EXCLUSION CRITERIA:
- 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;
- Female of childbearing potential not willing to practice barrier methods of birth control.
- CONTINUATION CRITERIA:
- Fulfills A or B or both: A) Confirmed complicated MRSA bacteremia B) Possible or definite RIE caused by MRSA according to modified Duke criteria;
- Infecting S. aureus strain susceptible to vancomycin;
- Infecting S. aureus strain susceptible to daptomycin;
- Appropriate treatment of any foci of infection within first 3 days of study;
- Removal of any intravascular foreign material not allowed per inclusion criteria within first 3 days of study;
- Removal of any percutaneous or implanted catheters not allowed per inclusion criteria within first 3 days of study.
Exclusion
Key Trial Info
Start Date :
September 17 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00695903
Start Date
September 17 2008
End Date
October 1 2010
Last Update
December 24 2018
Active Locations (2)
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1
East Carolina University
Greenville, North Carolina, United States
2
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195