Clindamycin as an alternative to vancomycin in patients undergoing aortic cardiac surgery with extracorporeal circulation (ECC): a prospective single-center pharmacokinetic study _ CLINDAPASS
Date de révision : 27/04/2026
25 participants
Homme Femme
A partir de 18 ans
Date de début de recrutement : 26/04/2026
Critères :
Critères d'inclusion :
- Adult ≥ 18 years
- Cardiac surgery under EEC
- 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
- Patient's oral and written comprehension of French
- Negative pregnancy test and effective contraception (according to CTFG recommendations) during treatment for women of childbearing age
- Men of childbearing age with effective contraception (as recommended by the CTFG) during treatment
- Social security affiliation
- Patient able to understand the objectives of the study and comply with the requirements of the protocol
Critères d'exclusion :
- Known hypersensitivity/allergy to clindamycin, to lincomycin and any other excipient listed in the SmPC
- Mental state rendering the patient unable of understanding the whole 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
- 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 hepatic insufficiency (prothrombin rate<50% excluding anticoagulant therapy) or Child B and C cirrhosis
- Chronic renal failure patients with creatinine clearance < 60 mL/min and/or on chronic dialysis
- Pregnant or breast-feeding women
- Immunosuppressed patients receiving triple antiviral therapy
- Women or men of childbearing age without effective contraception
- Serious, uncontrolled concomitant bacterial infections (e.g. septic shock)
- Patient 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
- Known hypersensitivity/allergy to penicillins/drugs of the beta-lactam family
- Contraindications to cefazolin or any of the auxiliary treatments
Lieux et contacts
Informations pratiques pour participer à cet essai.
Contacts
Sites des essais
Adresse
Centre Hospitalier Universitaire De Nantes
44000 Nantes France
Comment postuler ?
Pour participer à cet essai clinique, veuillez contacter la personne responsable de l'étude. Vous trouverez ses coordonnées dans la section "Lieux et contacts", puis "Contacts".