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Could a common antibiotic replace vancomycin in heart surgery?

NCT ID NCT07267013

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • CHU Nantes

    RECRUITING

    Nantes, France, 44000, France

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