Status:
COMPLETED
Pharmacokinetics of Daptomycin During Cardiopulmonary Bypass Surgery
Lead Sponsor:
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborating Sponsors:
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Hartford Hospital
Conditions:
Late Effects of Surgery
Staphylococcus Aureus
Eligibility:
All Genders
19-74 years
Phase:
PHASE3
Brief Summary
This investigation is a prospective, open-label pharmacokinetic study of daptomycin prophylaxis in patients undergoing coronary artery bypass graft surgery without valvular replacement.
Detailed Description
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...
Eligibility Criteria
Inclusion
- Hospitalized patients, awaiting scheduled elective coronary artery bypass graft (CABG) surgery without valve replacement surgery
- Age \> 18 years and \< 75 years
- BMI between 18.5 and 35.0 kg/meters-squared
- Crcl \> 50 ml/minute calculated based on Cockcroft Gault equation
- No known active or suspected infection(s)
- Ability to complete the informed consent process
- Negative pregnancy test (for women of childbearing age)
Exclusion
- History of allergic reaction to daptomycin or components of daptomycin
- Receipt of daptomycin within 7 days prior to the surgery
- Elevated CPK levels (defined as \> 3 times the upper limits of known normal)
- History of myopathy or complaints consistent with myopathy
- Current or planned use of mycophenolate mofetil, mycophenolic acid, or tobramycin during the subjects' current hospitalization (all of which are known to interact with daptomycin)
- Inability to complete the informed consent process because of problems with mental capacity
- Pregnancy and/or breast feeding
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00701636
Start Date
July 1 2008
End Date
October 1 2010
Last Update
August 29 2016
Active Locations (1)
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1
Harbor-UCLA Medical Center
Torrance, California, United States, 90509