Actively Recruiting
Clindamycin as an Alternative to Vancomycin in Patients Undergoing Aortic Cardiac Surgery With Extracorporeal Circulation (ECC)
Led by Nantes University Hospital · Updated on 2026-04-28
25
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Antibiotic prophylaxis is essential for all types of cardiac surgery under Extracorporeal Circulation (ECC), in order to reduce the incidence of surgical site infection (SSI). However, many patients are allergic to beta-lactam antibiotics. All the more, vancomycin antibiotic recommended as replacement is not without adverse effects and frequently administered in an inappropriate manner in terms of pre-intervention timing, linked to its complex use on peripheral venous lines complicated by venotoxicity. Non-compliance with the correct use of antibiotic prophylaxis in surgery is responsible for nosocomial infections, which have an impact on both the patient and the healthcare establishment in terms of costs, particularly in cardiac surgery. Drug pharmacokinetics are more complex under bypass surgery (high volume of distribution), and studies are needed to determine the correct administration and diffusion of drugs. In this respect, clindamycin is an antibiotic already used in antibiotic prophylaxis for other surgeries (thoracic, orthopedic...) in cases of allergy to beta-lactam antibiotics, but to date there are no studies examining the pharmacokinetics of this molecule in the context of cardiac surgery under ECC. The aim of this protocol is to demonstrate the feasibility of using clindamycin in patients undergoing ECC surgery, by verifying that the plasma concentration of clindamycin exceeds the minimum inhibition concentration (MIC) of the main bacteria involved in mediastinitis throughout the surgical procedure.
CONDITIONS
Official 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...
- Adult 18 years of age or older
- Scheduled cardiac surgery under extracorporeal circulation
- Surgery planned in the morning at least 24 hours before operation
- Able to provide written informed consent before starting the study
- Understands spoken and written French
- Negative pregnancy test and effective contraception for women of childbearing age
- Effective contraception for men of reproductive age
- Registered with social security
- Able to understand study goals and follow protocol requirements
You will not qualify if you...
- Known allergy to clindamycin, lincomycin, or excipients
- Known allergy to penicillins or beta-lactam antibiotics
- Currently on antibiotics other than cefazolin
- Already taking clindamycin at study start
- Body mass index over 35
- Undergoing aortic arch surgery
- Undergoing coronary artery bypass graft surgery
- Surgery for suspected endocarditis
- Chronic renal failure with creatinine clearance below 60 mL/min or on dialysis
- Hepatic insufficiency with prothrombin rate below 50% or Child B/C cirrhosis
- Immunosuppressed receiving triple antiviral therapy
- Pregnant or breastfeeding
- Women or men of childbearing age without effective contraception
- Serious uncontrolled bacterial infections such as septic shock
- Legal restrictions on liberty (guardianship, curatorship, etc.)
- Not registered with social security
- Participating in another therapeutic study with overlapping exclusion period
- Contraindications to cefazolin or related treatments
- Mental incapacity preventing understanding of the study
- Investigator, staff member, or close relative involved in the study
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Trial Site Locations
Total: 1 location
1
CHU Nantes
Nantes, France, France, 44000
Actively Recruiting
Research Team
J
Julien CADIET, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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