Clindamycin as an Alternative to Vancomycin in Patients Undergoing Aortic Cardiac Surgery With Extracorporeal Circulation (ECC)

Recruiting now · Phase 2

Conditions studied: Aortic Surgery, Extracorporeal Circulation

In brief

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.

Key facts

Study ID

NCT07267013

Run by

Nantes University Hospital

People needed

25

Starts

2026-04-21

Expected to finish

2026-10-21

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult ≥ 18 years of age,
• Cardiac surgery under ECC
• Surgery scheduled in the morning (added to the schedule at least 24 hours before the operation and starting at 8 a.m. in order to send blood tests during working hours).
• Written, informed consent from the patient before the start of the protocol.
• The patient must understand spoken and written French
• Negative pregnancy test and effective contraception (according to CTFG recommendations) during treatment for women of childbearing age
• Men of reproductive age using effective contraception (according to CTFG recommendations) during treatment
• Social security affiliation
• Patient able to understand the objectives of the study and comply with the requirements of the protocol

You may not qualify if…

• Known hypersensitivity/allergy to clindamycin, lincomycin, and any other excipient listed in the SmPC
• Known hypersensitivity/allergy to penicillins/drugs of the beta-lactam family
• Patient on antibiotics other than cefazolin prior to surgery
• Patient already on clindamycin at inclusion,
• BMI>35
• Aortic arch surgery
• Coronary artery bypass graft surgery
• Surgery for suspected endocarditis
• Patients with chronic renal failure with creatinine clearance < 60 mL/min and/or undergoing chronic dialysis
• Patients with hepatic insufficiency (prothrombin rate<50% excluding anticoagulant therapy) or Child B and C cirrhosis
• Immunosuppressed patients receiving triple antiviral therapy
• Pregnant or breast-feeding women
• Women or men of childbearing age without effective contraception
• Serious, uncontrolled concomitant bacterial infections (e.g. septic shock)
• Patients deprived of their liberty by judicial or administrative decision (guardianship, curatorship, safeguard of justice)
• Patient not registered with social security
• Participation in any other therapeutic study with an exclusion period still in effect at the time of inclusion, or planned participation in another therapeutic study while taking clindamycin
• Contraindications to cefazolin or any of the ancillary treatments
• Mental state rendering the patient incapable of understanding the entire study
• Patient being the investigator or any other member of the research team or being a relative of the investigator directly involved in the trial, including assistant physicians, pharmacists, nurses, and study coordinators

Where it is running

• CHU Nantes — Nantes, France, France (enrolling)

Full record on ClinicalTrials.gov

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