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Clindamycin as an alternative to vancomycin in patients undergoing aortic cardiac surgery with extracorporeal circulation (ECC): a prospective single-center pharmacokinetic study _ CLINDAPASS
EU CTIS ID: 2025-521555-23-00
What this study is testing
Demonstrate the feasibility of using clindamycin in patients undergoing EEC surgery by verifying that plasma clindamycin concentrations remain above the minimum inhibition concentration (MIC) of the main bacteria involved in mediastinitis throughout the surgical procedure
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
- Isolated 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.