Actively Recruiting
Clindamycin as an Alternative to Vancomycin in Patients Undergoing Aortic Cardiac Surgery With Extracorporeal Circulation (ECC): a Prospective Single-center Pharmacokinetic Study
Led by Nantes University Hospital · Updated on 2026-04-28
25
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of clindamycin as an alternative antibiotic for patients undergoing cardiac surgery with Extracorporeal Circulation (ECC). This study focuses on the pharmacokinetics of clindamycin, especially since many patients allergic to beta-lactam antibiotics currently receive vancomycin, which can cause adverse effects and is difficult to administer properly. The trial aims to verify that clindamycin maintains plasma concentrations above the minimum inhibition concentration (MIC) of key bacteria throughout surgery, potentially reducing surgical site infections. The study involves administering clindamycin intravenously during cardiac surgery with ECC. Patients receive an initial dose of 900 mg clindamycin slowly over 30 minutes after the first cefuroxime bolus, with a possible additional dose of 600 mg if surgery extends beyond four hours. Blood samples are taken at the start of surgery, hourly, and at sternal closure to measure clindamycin levels. The study also examines clindamycin's diffusion in pericardial fatty tissue and tracks adverse events and protocol adherence. Participants are adults scheduled for cardiac surgery with ECC, consenting to the study and able to comply with its requirements. Researchers monitor plasma clindamycin concentrations during surgery using arterial catheter blood samples, minimizing discomfort. Outcomes include pharmacokinetic parameters, variability factors, pericardial tissue diffusion, and rates of post-operative mediastinitis and complications up to three months after surgery. Safety is assessed throughout hospitalization, and adherence to dosing protocols is tracked.
CONDITIONS
Brief Title
Clindamycin as an Alternative to Vancomycin in Patients Undergoing Aortic Cardiac Surgery With Extracorporeal Circulation (ECC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Scheduled for cardiac surgery under Extracorporeal Circulation (ECC)
- Surgery scheduled in the morning, added at least 24 hours before operation starting at 8 a.m.
- Provide written informed consent before starting the protocol
- Able to understand spoken and written French
- Negative pregnancy test and use effective contraception if a woman of childbearing age
- Men of reproductive age using effective contraception during treatment
- Affiliated with social security
- Able to understand the study objectives and comply with protocol requirements
You will not qualify if you...
- Known allergy to clindamycin, lincomycin, or any excipient in the medication
- Known allergy to penicillins or beta-lactam antibiotics
- Taking antibiotics other than cefazolin prior to surgery
- Already receiving clindamycin at inclusion
- Body mass index (BMI) greater than 35
- Undergoing aortic arch surgery
- Undergoing coronary artery bypass graft surgery
- Surgery for suspected endocarditis
- Chronic renal failure with creatinine clearance less than 60 mL/min or on chronic dialysis
- Hepatic insufficiency with prothrombin rate below 50% or Child B and C cirrhosis
- Immunosuppressed patients on triple antiviral therapy
- Pregnant or breastfeeding women
- Women or men of childbearing age without effective contraception
- Severe uncontrolled bacterial infections such as septic shock
- Deprived of liberty by judicial or administrative decision
- Not registered with social security
- Participation in another therapeutic study with exclusion period or planned participation while taking clindamycin
- Contraindications to cefazolin or ancillary treatments
- Mental state preventing understanding of the study
- Investigator, research team members, or relatives directly involved in the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During the scheduled cardiac surgery and up to skin closure
Participants receive clindamycin during scheduled cardiac surgery with extracorporeal circulation, including possible reinjection if surgery lasts longer than 4 hours.
1 surgical visit (in-person)
Duration - Up to 3 months post-operatively
Participants are monitored for pharmacokinetics, adverse events, and post-operative outcomes including infection and morbidity up to 3 months after surgery.
Visits at H+6, H+24 post-surgery and additional follow-up visits up to 3 months
Trial Site Locations
Total: 1 location
1
CHU Nantes
Nantes, France, France, 44000
Actively Recruiting
Research Team
J
Julien CADIET, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here