NCT07267013 Clindamycin as an Alternative to Vancomycin in Patients Undergoing Aortic Cardiac Surgery With Extracorporeal Circulation (ECC)
| NCT ID | NCT07267013 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Nantes University Hospital |
| Condition | Aortic Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2026-04-21 |
| Primary Completion | 2026-07-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 25 participants in total. It began in 2026-04-21 with a primary completion date of 2026-07-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07267013 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07267013 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07267013 currently recruiting?
Yes, NCT07267013 is actively recruiting participants. Contact the research team at julien.cadiet@chu-nantes.fr for enrollment information.
Where is the NCT07267013 trial being conducted?
This trial is being conducted at Nantes, France.
Who is sponsoring the NCT07267013 clinical trial?
NCT07267013 is sponsored by Nantes University Hospital. The trial plans to enroll 25 participants.