Pharmacokinetics Clinical Trial
Official title:
Pharmacokinetics of Daptomycin During Cardiopulmonary Bypass Surgery
This investigation is a prospective, open-label pharmacokinetic study of daptomycin prophylaxis in patients undergoing coronary artery bypass graft surgery without valvular replacement.
Cardiothoracic surgery is a commonly performed procedure in the United States. Many sites
previously used cefazolin, an antibiotic, as standard prophylaxis to prevent surgical site
infections. However, given most bacteria causing surgical site infections are now resistant
to cefazolin, most center are using vancomycin, an alternative antibiotic, as surgical
antibiotic prophylaxis. However, some patients cannot take vancomycin, and there are no well
studied alternatives to vancomycin for surgical prophylaxis. Therefore, we are studying
daptomycin, a newer FDA-approved antibiotic, as prophylaxis against surgical site infections
among patients undergoing cardiothoracic bypass (CPB) with coronary artery bypass graft
surgery (CABG). Our study will not be powered to see if daptomycin is as effective as
vancomycin at preventing surgical site infections. Instead, the purpose of this study is to
validate that adequate levels of antibiotics are present in patients' blood during
cardiothoracic bypass surgery.
Study subjects in the intervention group will be followed from the time of enrollment in the
study until their discharge from the hospital, or up to 7 days following administration of
daptomycin, whichever comes first.
The first 15 subjects enrolled will receive the intervention drug daptomycin as surgical
antibiotic prophylaxis and the following 15 subjects will be enrolled as matched controls
and will receive the standard of care surgical prophylaxis per the patient's treating
physicians. The controls will undergo monitoring for the same safety outcomes that the
patients who received daptomycin will undergo.
Subjects enrolled in the intervention group will receive a single intravenous administration
of daptomycin 8 mg/kg 30-60 minutes prior to surgery (incision). Blood samples will be drawn
by the Research Coordinator. A total of 85 mL of blood will be collected during the study. A
total of 14 blood samples will be collected: 4 samples at the Pre-CPB phase, 4 samples
during the CPB procedure, and 6 samples Post-CPB. Total plasma daptomycin concentrations
will be determined utilizing standard high-performance liquid chromatography techniques.
Plasma concentrations will be compared to the minimum inhibitory concentrations (MIC90) of
the common pathogens involved in surgical site infections, specifically Staphylococcus
aureus and coagulase negative Staphylococcus.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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