Phase 3 N=30 Prevention

Pharmacokinetics of Daptomycin During Cardiopulmonary Bypass Surgery

Late Effects of Surgery · Staphylococcus Aureus · Surgical Site Infection

Bottom Line

View on ClinicalTrials.gov: NCT00701636 ↗

Enrolled (actual)

Serious AEs

10.0%

Results posted

Aug 2016

Primary outcome: Primary: Mean Daptomycin Concentrations at 12, 18, 24, and 48 h — 22.7; 16.2; 12.0; 3.5 mcg/ml

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: daptomycin (Drug)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Primary completion: Oct 2010

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	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00701636). 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.