Clindamycin as an Alternative to Vancomycin in Patients Undergoing Aortic Cardiac Surgery With Extracorporeal Circulation (ECC)

NCT07267013 | Recruiting Phase 2 DMC

• 2 other identifiers: RC24_05492025-521555-23-00
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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. All the more, vancomycin antibiotic recommended as replacement is not without adverse effects and frequently administered in an inappropriate manner in terms of pre-intervention timing, linked to its complex use on peripheral venous lines complicated by venotoxicity. Non-compliance with the correct use of antibiotic prophylaxis in surgery is responsible for nosocomial infections, which have an impact on both the patient and the healthcare establishment in terms of costs, particularly in cardiac surgery. Drug pharmacokinetics are more complex under bypass surgery (high volume of distribution), and studies are needed to determine the correct administration and diffusion of drugs. In this respect, clindamycin is an antibiotic already used in antibiotic prophylaxis for other surgeries (thoracic, orthopedic...) in cases of allergy to beta-lactam antibiotics, but to date there are no studies examining the pharmacokinetics of this molecule in the context of cardiac surgery under ECC. The aim of this protocol is to demonstrate the feasibility of using clindamycin in patients undergoing ECC surgery, by verifying that the plasma concentration of clindamycin exceeds the minimum inhibition concentration (MIC) of the main bacteria involved in mediastinitis throughout the surgical procedure.

Conditions

Extracorporeal Circulation; Aortic Surgery

Keywords

clindamycin; extracorporeal circulation (EEC); antibiotics

Outcome Measures

Primary Outcomes (1)

• Plasma clindamycin concentrations

  To demonstrate the feasibility of using clindamycin in patients undergoing ECC and to assure that plasma clindamycin concentrations remain above the minimum inhibition concentration (MIC) of the main bacteria involved in mediastinitis, estimated free plasma clindamycin concentration will be verify throughout surgery. The free plasma concentration of clindamycin is estimated by measuring the total plasma concentration of clindamycin, based on a bound fraction of 80 to 94%.The epidemiological threshold MIC for S. aureus (ECOFF = 0.25 mg/L for clindamycin) was chosen for comparison with clindamycin concentrations, given that this bacterium is the main one implicated in mediastinitis.

  H0 (at incision), then every hour, and at the end of surgery (defined as sternal closure)

Secondary Outcomes (7)

• Determine the pharmacokinetic parameters of clindamycin under ECC

  At H0 (at incision), then every hour, and at the end of surgery (defined as sternal closure)

• Determine the factors of variability in clindamycin pharmacokinetics for patients under ECC surgery

  Post-ECC at H+6 and H+24

• Determining the diffusion of clindamycin in pericardial fatty tissue

  At the start of the operation (sternotomy) and when the pericardium is closed

• Description of adverse events according to NCI CTCAE V5 criteria

  From first injection of clindamycin to end of hospitalization

• Adherence to Good Clinical Practice clindamycin injection protocol

  From first injection of clindamycin to the end of surgery (defined as sternal closure)

Study Arms (1)

Clindamycin

EXPERIMENTAL

Drug: Clindamycin

Interventions

Clindamycin DRUG

Clindamycin used in the study corresponds to commercial forms of injectable clindamycin : KBI 600 mg/4 mL injectable solution, ampoule. * 1 ampoule contains 600 mg Clindamycin phosphate (expressed as Clindamycin base). * Excipients: edetate disodium, benzyl alcohol, sodium hydroxide, water for injection. * Dosage form: injectable solution 10minutes after injecting the first bolus of cefuroxime, clindamycin is reconstituted in 50 mL of 0.9% NaCl, then 900 mg of clindamycin is administered as a slow IV over 30 minutes. At H+4 from the end of the clindamycin injection, if skin closure is not effective, clindamycin at a dose of 600 mg in 50 mL 0.9% NaCl is re-injected over 20 minutes.

Clindamycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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
• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU Nantes

Nantes, France, 44000, France

RECRUITING

MeSH Terms

Interventions

Clindamycin

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates

Central Study Contacts

Julien CADIET, MD

CONTACT

+33(0)2.44.76.86.86; julien.cadiet@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase 2 interventional study, single-center, prospective and uncontrolled study conducted at Nantes University Hospital in the CTCV (Thoracic and Cardiovascular Surgery) anesthesia and intensive care unit.

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 5, 2025
• Study Start: April 21, 2026
• Primary Completion (Estimated): July 21, 2026
• Study Completion (Estimated): October 21, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

FR (1)