A Pilot Study of Daptomycin for Antimicrobial Prophylaxis (NCT00572260) | Clinical Trial Compass
TerminatedPhase 4
A Pilot Study of Daptomycin for Antimicrobial Prophylaxis
Stopped: Study closed. PI left the institution.
United States11 participantsStarted 2008-01
Plain-language summary
The goals of the study are to evaluate the feasibility of using daptomycin as a prophylactic antimicrobial agent in patients undergoing cardiac surgery, to determine the rates of surgical site infection, and to evaluate the occurrence of adverse events.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Provide signed and dated informed consent and are willing to receive the study medication
✓. Age ≥ 18 years of age
✓. If a female of childbearing potential is willing to practice at least one method of birth control during treatment and for at least 28 days after treatment with study medication:
✓. barrier methods of birth control (e.g., condoms, diaphragms together with spermicidal foam or gel, or presence of IUD) or
✓. surgical sterilization, approved hormonal contraceptives (such as birth control pills, depo-Provera, or Lupron Depot), or IUD are all acceptable.
✓. If a female of childbearing potential, serum HCG negative within 24 hours of scheduled surgery.
✓. Planned cardiac surgery procedures meeting current Duke criteria to receive anti-microbial prophylaxis active against MRSA:
Exclusion criteria
✕. Hypersensitivity to daptomycin
✕. Inability to receive standard prophylaxis agents (cefuroxime and rifampin) for any reason
✕. Staphylococcal bacteremia at the time of enrollment
✕. Diagnosis of S. aureus or coagulase negative staphylococcus pacemaker/defibrillator infection within the preceding 18 months
✕. Patient is undergoing emergency CABG
What they're measuring
1
Rate of Patients Receiving Antimicrobial Prophylaxis Within the Appropriate Timeframe Before Incision