Could a common antibiotic replace vancomycin in heart surgery?
NCT ID NCT07267013
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether clindamycin, an antibiotic already used in other surgeries, can be a safe and effective alternative to vancomycin for preventing infections in patients undergoing aortic heart surgery with a heart-lung machine. The trial will enroll 25 adults and measure clindamycin levels in the blood during surgery to ensure it stays high enough to kill bacteria. It aims to address the need for better options for patients allergic to standard antibiotics.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Clindamycin
- What this could lead to
- If successful, this could provide a safer, easier-to-use antibiotic option for heart surgery patients who are allergic to penicillin.
- What could go wrong
- This is a very small, early-phase study (25 people) focused on drug levels, not on preventing infections. It may not prove clindamycin works as well as current options.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU Nantes
RECRUITINGNantes, France, 44000, France
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