Pharmacokinetics of Daptomycin During Cardiopulmonary Bypass Surgery

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This investigation is a prospective, open-label pharmacokinetic study of daptomycin prophylaxis in patients undergoing coronary artery bypass graft surgery without valvular replacement.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Los Angeles Biomedical Research Institute; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Collaborators: Cubist Pharmaceuticals LLC; Hartford Hospital; Western University of Health Sciences
• Treatments: Anti-Bacterial Agents; Daptomycin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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