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

Study acronym: CLINDAPASS
StatusRecruiting
PhasePhase 2
Started2026-04-21
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 28, 2026 (before its estimated July 21, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-04-27
notable
Study Status, Contacts/Locations v2
Recruitment opened
Primary completion date2026-07-30→2026-07-21
Completion date2026-10-30→2026-10-21
Start dateestimated 2026-03-30→confirmed 2026-04-21
Study sitesdetails revised at 1 of 1 site
2026-01-23
minor
Study Status v1
Primary completion date2026-07-15→2026-07-30
Completion date2026-07-15→2026-10-30
Start date2026-01-15→2026-03-30
2025-11-24
minor
Original filing
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.
Trial Details
NCT Number NCT07267013
Lead Sponsor Nantes University Hospital
Conditions Aortic Surgery, Extracorporeal Circulation
Enrollment 25 participants
Start Date 2026-04-21
Primary Completion 2026-07-21 (estimated)
Study Completion 2026-10-21 (estimated)
Updated on ClinicalTrials.gov 2026-04-28