Phase 3
Completed N=30
Pharmacokinetics of Daptomycin During Cardiopulmonary Bypass Surgery
Late Effects of Surgery · Staphylococcus aureus · Surgical Site Infection
Source: ClinicalTrials.gov NCT00701636 ↗
Enrolled (actual)
30
Serious AEs
10.0%
Results posted
Aug 2016
Primary outcomePrimary: Mean Daptomycin Concentrations at 12, 18, 24, and 48 h — 22.7; 16.2; 12.0; 3.5 mcg/ml
◆ Published Evidence
Emerging
8citations · ~1 / year
Prospective, open-label investigation of the pharmacokinetics of daptomycin during cardiopulmonary bypass surgery.
Summary
This investigation is a prospective, open-label pharmacokinetic study of daptomycin prophylaxis in patients undergoing coronary artery bypass graft surgery without valvular replacement.
Linked Publications
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Prospective, open-label investigation of the pharmacokinetics of daptomycin during cardiopulmonary bypass surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Daptomycin Concentrations at 12, 18, 24, and 48 h |
22.7; 16.2; 12.0; 3.5 | — |
Eligibility Criteria
Inclusion Criteria
- Hospitalized patients, awaiting scheduled elective coronary artery bypass graft (CABG) surgery without valve replacement surgery
- Age > 18 years and 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
Data sourced from ClinicalTrials.gov (NCT00701636) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.