Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-24 @ 7:19 PM
NCT ID:
NCT00695903
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00695903
Study Brief:
Protocol Section:
NCT00695903