Aortic SurgeryPhase 2CLINDAPASSNCT07267013
Clindamycin as an Alternative to Vancomycin in Patients Undergoing Aortic Cardiac Surgery With Extracorporeal Circulation (ECC)
A Phase 2 study testing Clindamycin in people with Aortic Surgery and Extracorporeal Circulation, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Surgery, Extracorporeal Circulation
- What is being tested?
- Clindamycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 21 Apr 2026to 21 Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Nantes
Nantes, France, 44000
Julien CADIET, Doctor, +33(0)244768686 ext. +33, julien.cadiet@chu-nantes.fr
About this study
Official title: Clindamycin as an Alternative to Vancomycin in Patients Undergoing Aortic Cardiac Surgery With Extracorporeal Circulation (ECC): a Prospective Single-center Pharmacokinetic Study
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.
Read more
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.
Read the detailed description
ECC is indispensable for cardiac surgery, but this assistance modifies the pharmacological properties of drugs, with a particular increase in the volume of distribution of antibiotics such as clindamycin. All these factors lead to an increase in the dosage of certain drugs and more frequent injections.
Robust data on percutaneous clindamycin treatment would therefore enable to improve the management of this type of patient, with real impact.
There are currently no pharmacological studies justifying the use of clindamycin to combat nosocomial infections in cardiac surgery, despite the fact that its anti-bacterial spectrum is identical to that of the antibiotics currently used in patients (methicillin-sensitive Staphylococcus aureus (MSSA)).
Clindamycin is simpler to use and does not induce venotoxicity. The fact that the patient is undergoing bypass surgery means that pharmacokinetic studies can be carried out with several blood samples taken from the arterial pressure catheter routinely inserted in all surgical patients, in order to limit the volume of blood taken and avoid any discomfort for the patient. This would make it possible to check the plasma stability of this antibiotic over several periods, with reinjections if necessary (if surgery > 4h).
The hypotheses are that clindamycin (i) is simple to use, (ii) has correct and stable diffusion kinetics in patients undergoing scheduled cardiac surgery with ECC (iii) is well tolerated by patients (iv) has an estimated free plasma concentration above the epidemiological threshold Minimal Inhibition Concentration (MIC) of Staphylococcus aureus and therefore provides sufficient protection against SSI.
- Conditions
- Aortic Surgery, Extracorporeal Circulation
- Being tested
- Clindamycin
- Keywords
- clindamycin, extracorporeal circulation (EEC), antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClindamycinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Clindamycin | Experimental | Not described Receives: Drug: Clindamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Volume of distribution, clearance, elimination half-life, quantity of intra-operative vascular filling (in ml) including blood transfusions: number and type of intra-operative LBS (labile blood products)
Measured: 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
Collection of weight, height (calculation of BMI), collection of usual post-CEC biological data (creatinemia with calculation of GFR, ASAT/ALAT, total and conjugated bilirubinemia, PAL, γ-GT, protidemia with addition of α-1 acid glycoprotein at induction), qualitative record of CYP3A4/5 inducer/inhibitor drugs, CEC modalities (duration, type and quantity of priming solution, type of cardioplegia, body temperature), blood transfusion and volume reprocessed by Cell-Saver©.
Measured: Post-ECC at H+6 and H+24
Determining the diffusion of clindamycin in pericardial fatty tissue
Tissue determination of clindamycin in pericardial fat and correlation with plasma levels (biocollection, ancillary study
Measured: At the start of the operation (sternotomy) and when the pericardium is closed
Description of adverse events according to NCI CTCAE V5 criteria
Recording of AEs and SAEs, collection of all clinical signs indicative of anaphylaxis on medical examination
Measured: From first injection of clindamycin to end of hospitalization
Adherence to Good Clinical Practice clindamycin injection protocol
Recording of clindamycin injection duration, time of reinjections and duration of reinjections, calculation of delta between time of end of clindamycin injection and start of surgical incision
Measured: From first injection of clindamycin to the end of surgery (defined as sternal closure)
Rate of post-operative mediastinitis (up to 3 months post-operatively)
Rate of post-operative mediastinitis defined as a post-operative nosocomial cardiac surgery infection at the surgical site (mediastinum) requiring repeat surgery (drainage lavage) and prolonged antibiotic therapy. Collection of data from the patient's file, as the patient was systematically referred to the Nantes University Hospital. Collection of bacterial ecology
Measured: From inclusion to 3 months post-operatively (M3)
Post-op morbidity and mortality
Mortality at 3 months (telephone call)
Measured: At 3 months (M3) post-operative (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start21 Apr 2026
- Primary completion21 Jul 2026 (estimated)
- Study completion21 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic SurgeryStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267013
- Sponsor's protocol ID
- RC24_0549
- Other IDs
- 2025-521555-23-00, 2025
- Acronym
- CLINDAPASS
- Status last verified
- Apr 2026
- First submitted
- 24 Nov 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clindamycin as an Alternative to Vancomycin in Patients Undergoing Aortic Cardiac Surgery With Extracorporeal Circulation (ECC): a Prospective Single-center Pharmacokinetic Study
- ClinicalTrials.gov ID
- NCT07267013
- Acronym / sponsor ID
- CLINDAPASS / RC24_0549
- Conditions
- Aortic Surgery, Extracorporeal Circulation
- Keywords
- clindamycin, extracorporeal circulation (EEC), antibiotics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 21 Jul 2026 (estimated)
- Study completion
- 21 Oct 2026 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
ECC is indispensable for cardiac surgery, but this assistance modifies the pharmacological properties of drugs, with a particular increase in the volume of distribution of antibiotics such as clindamycin. All these factors lead to an increase in the dosage of certain drugs and more frequent injections.
Robust data on percutaneous clindamycin treatment would therefore enable to improve the management of this type of patient, with real impact.
There are currently no pharmacological studies justifying the use of clindamycin to combat nosocomial infections in cardiac surgery, despite the fact that its anti-bacterial spectrum is identical to that of the antibiotics currently used in patients (methicillin-sensitive Staphylococcus aureus (MSSA)).
Clindamycin is simpler to use and does not induce venotoxicity. The fact that the patient is undergoing bypass surgery means that pharmacokinetic studies can be carried out with several blood samples taken from the arterial pressure catheter routinely inserted in all surgical patients, in order to limit the volume of blood taken and avoid any discomfort for the patient. This would make it possible to check the plasma stability of this antibiotic over several periods, with reinjections if necessary (if surgery > 4h).
The hypotheses are that clindamycin (i) is simple to use, (ii) has correct and stable diffusion kinetics in patients undergoing scheduled cardiac surgery with ECC (iii) is well tolerated by patients (iv) has an estimated free plasma concentration above the epidemiological threshold Minimal Inhibition Concentration (MIC) of Staphylococcus aureus and therefore provides sufficient protection against SSI.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Clindamycin | Experimental | Drug: Clindamycin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClindamycinClindamycin 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. | Drug | Clindamycin |
Primary outcome
Plasma clindamycin concentrations
Time frame: H0 (at incision), then every hour, and at the end of surgery (defined as sternal closure)
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.
7 secondary outcomes
Determine the pharmacokinetic parameters of clindamycin under ECC
Time frame: 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
Time frame: Post-ECC at H+6 and H+24
Determining the diffusion of clindamycin in pericardial fatty tissue
Time frame: At the start of the operation (sternotomy) and when the pericardium is closed
Description of adverse events according to NCI CTCAE V5 criteria
Time frame: From first injection of clindamycin to end of hospitalization
Adherence to Good Clinical Practice clindamycin injection protocol
Time frame: From first injection of clindamycin to the end of surgery (defined as sternal closure)
Rate of post-operative mediastinitis (up to 3 months post-operatively)
Time frame: From inclusion to 3 months post-operatively (M3)
Post-op morbidity and mortality
Time frame: At 3 months (M3) post-operative (follow-up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clindamycin in people with Aortic Surgery and Extracorporeal Circulation, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julien CADIET, MD (+33(0)2.44.76.86.86 ext. +33, julien.cadiet@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma clindamycin concentrations (time frame: H0 (at incision), then every hour, and at the end of surgery (defined as sternal closure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.