Clindamycin instead of vancomycin for aortic heart surgery with cardiopulmonary bypass

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study gives perioperative clindamycin to adults undergoing scheduled aortic cardiac surgery with extracorporeal circulation to characterize its plasma diffusion, stability, and tolerability under bypass conditions. Serial blood samples will be taken from the routine arterial catheter during surgery to measure clindamycin pharmacokinetics and determine whether additional intraoperative dosing is needed for procedures longer than four hours. Safety and tolerability will be monitored during and after surgery. The aim is to gather pharmacological data to support appropriate dosing of clindamycin for surgical site infection prophylaxis in this setting.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU Nantes
  Nantes, France, France Recruiting

Study contacts

• Study coordinator: Julien CADIET, MD
• Email: julien.cadiet@chu-nantes.fr
• Phone: +33(0)2.44.76.86.86

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.