Pharmacokinetics of Daptomycin During Cardiopulmonary Bypass Surgery

Completed · Phase 3

Conditions studied: Late Effects of Surgery, Staphylococcus Aureus, Surgical Site Infection

In brief

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

Key facts

Study ID

NCT00701636

Run by

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

People needed

30

Starts

2008-07-01

Expected to finish

2010-10-01

Last updated by the study team

2016-08-29

Who can join

Age: 19 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Harbor-UCLA Medical Center — Torrance, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.