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NCT07267013

PHASE2

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

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Clindamycin as an Alternative to Vancomycin in Patients Undergoing Aortic Cardiac Surgery With Extracorporeal Circulation (ECC): a Prospective Single-center Pharmacokinetic Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-03-30

Completion Date

2026-10-30

Last Updated

2026-01-26

Healthy Volunteers

Conditions

Aortic Surgery Extracorporeal Circulation

Interventions

DRUG

Clindamycin

Clindamycin used in the study corresponds to commercial forms of injectable clindamycin : KBI 600 mg/4 mL injectable solution, ampoule. * 1 ampoule contains 600 mg Clindamycin phosphate (expressed as Clindamycin base). * Excipients: edetate disodium, benzyl alcohol, sodium hydroxide, water for injection. * Dosage form: injectable solution 10minutes after injecting the first bolus of cefuroxime, clindamycin is reconstituted in 50 mL of 0.9% NaCl, then 900 mg of clindamycin is administered as a slow IV over 30 minutes. At H+4 from the end of the clindamycin injection, if skin closure is not effective, clindamycin at a dose of 600 mg in 50 mL 0.9% NaCl is re-injected over 20 minutes.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

CHU Nantes

Nantes, France, France