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New treatment option for Aortic Surgery
Official title Clindamycin as an Alternative to Vancomycin in Patients Undergoing Aortic Cardiac Surgery With Extracorporeal Circulation (ECC)
ClinicalTrials.gov ID: NCT07267013
What this study is testing
What is Clindamycin?
Clindamycin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for aortic surgery.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Written, informed consent from the patient before the start of the protocol.
- The patient must understand spoken and written French
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nantes, France, France
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nantes, France, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.