Clindamycin as an Alternative to Vancomycin in Patients Undergoing Aortic Cardiac Surgery With Ex… (NCT07267013) | Clinical Trial Compass
RecruitingPhase 2
Clindamycin as an Alternative to Vancomycin in Patients Undergoing Aortic Cardiac Surgery With Extracorporeal Circulation (ECC)
France25 participantsStarted 2026-04-21
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 b…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plasma clindamycin concentrations
Timeframe: H0 (at incision), then every hour, and at the end of surgery (defined as sternal closure)