Antibiotic ProphylaxisPhase 3PROPHYLOXITINNCT05755789
Intermittent Cefoxitin Administration Versus Loading Bolus Followed by Continuous Infusion for the Prevention of Surgical Site Infection in Colorectal Surgery
A Phase 3 study testing Loading bolus of cefoxitin, Intermittent cefoxitin and Continuous infusion of cefoxitin in people with Antibiotic Prophylaxis and Colorectal Surgery, run by Poitiers University Hospital at 19 sites in France.
Trial summary
The goal of this prospective, multicentre, double-blind, randomized clinical trial is to compare intermittent cefoxitin administration to loading bolus followed by continuous infusion for surgical antibiotic prophylaxis in colorectal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibiotic Prophylaxis, Colorectal Surgery
- What is being tested?
- Loading bolus of cefoxitin, Intermittent cefoxitin and Continuous infusion of cefoxitin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,000 participants
- Where
- 19 sitesFrance
- Study dates
- 22 Jun 2023to Jun 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 patients (≥18 years)
- Undergoing colorectal surgery (predictable duration > 90 min)
Who cannot join
- Patients with known history of hypersensitivity to cefoxitin or others beta-lactams
- Patients with extreme severe obesity (defined by a body mass index greater than 50 kg/m2)
- Patients with severe renal insufficiency (clearance creatinine < 30ml/min)
- Active bacterial infection at the time of surgery or recent antimicrobial therapy (up to 2 weeks before surgery) except for oral surgical antibiotic prophylaxis
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
France19 sites, 19 recruiting
- Recruiting
CHU Angers
Angers
Sigismond Lasocki, Pr
- Recruiting
Hopital privé Arras les Bonnettes
Arras
Matthias GAROT, Dr
- Recruiting
CHU Caen
Caen
Claire NICOLLE, Dr
- Recruiting
CHU Clermont Ferrand
Clermont-Ferrand
Marc GARNIER, Dr
- Recruiting
CHU Grenoble
Grenoble
Victor Schwindenhammer, Dr
- Recruiting
Centre Léon Bérard
Lyon
Cécile HANNEZO, Dr
- Recruiting
Hospices Civils Lyon
Lyon
Anne LI, Dr
- Recruiting
Institut Paoli Calmettes
Marseille
Marion FAUCHER, Dr
- Recruiting
CHRU Nancy
Nancy
Julien BIRCKENER, Dr
- Recruiting
CHU de Nantes
Nantes
Raphael CINOTTI, Pr
- Recruiting
Hopital Européen Gorges Pompidou
Paris
Jean Sebastien AUBERT, Pr
- Recruiting
Centre Hospitalier de Poitiers
Poitiers, Vienne, 86021
Matthieu BOISSON, PU-PH, 05.49.44.46.35, matthieu.boisson@chu-poitiers.fr
- Recruiting
Clinique Mutualiste la Sagesse
Rennes
Stéphanie CHEVALIER, Dr
- Recruiting
Hôpital Privé Rennais Cesson Sevigné
Rennes
Christophe AVELINE, Dr
- Recruiting
CH St Brieuc
Saint-Brieuc
Sylvain LECOEUR, Dr
- Recruiting
CHU St Etienne
Saint-Etienne
Maxime WODEY, Dr
- Recruiting
Hopitaux de Strasbourg
Strasbourg
Charles LAGARRIGUE, Dr
- Recruiting
CHU Toulouse Rangueil
Toulouse
Guillaume PORTA BONETE, Dr
- Recruiting
CH Bretagne Atlantique vannes
Vannes
Benjamin PUISNEY, Dr
About this study
Official title: Intermittent Cefoxitin Administration Versus Loading Bolus Followed by Continuous Infusion for the Prevention of Surgical Site Infection in Colorectal Surgery: a Multicentre, Double-blind, Randomized Controlled Clinical Trial
The goal of this prospective, multicentre, double-blind, randomized clinical trial is to compare intermittent cefoxitin administration to loading bolus followed by continuous infusion for surgical antibiotic prophylaxis in colorectal surgery.
The main objective is to demonstrate the superiority of a loading dose of cefoxitin followed by continuous infusion over standard of care boluses in reducing SSI within 30 days after colorectal surgery
- Conditions
- Antibiotic Prophylaxis, Colorectal Surgery
- Being tested
- Loading bolus of cefoxitin, Intermittent cefoxitin, Continuous infusion of placebo, Continuous infusion of cefoxitin, Intermittent placebo
- Keywords
- cefoxitin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loading bolus of cefoxitinDrug
Cefoxitin [2g] before incision
Intermittent cefoxitinDrug
Additional bolus of cefoxitin [1g] every 2 hours until the end of surgical closure
Continuous infusion of placeboDrug
Continuous infusion of placebo from the end of the loading bolus until the end of surgical closure
Continuous infusion of cefoxitinDrug
Continuous infusion of cefoxitin [0.5g/h] from the end of the loading bolus until the end of surgical closure
Intermittent placeboDrug
Additional bolus of placebo every 2 hours until the end of surgical closure
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (innovative administration scheme) | Experimental | Continuous infusion of cefoxitin + Intermittent placebo Receives: Drug: Loading bolus of cefoxitin; Drug: Continuous infusion of cefoxitin; Drug: Intermittent placebo |
| Control group (recommended administration scheme) | Active comparator | Intermittent cefoxitin + Continuous infusion of placebo Receives: Drug: Loading bolus of cefoxitin; Drug: Intermittent cefoxitin; Drug: Continuous infusion of placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
Proportion of patients with any surgical site infection according to the CDC criteria
Measured: within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start22 Jun 2023
- Primary completionMay 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Antibiotic ProphylaxisStudies of the same condition, open and under way.
- More trials run by Poitiers 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05755789
- Sponsor's protocol ID
- PROPHYLOXITIN
- Acronym
- PROPHYLOXITIN
- Status last verified
- Apr 2024
- First submitted
- 23 Feb 2023
- Last updated
- 23 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Saint-Genis Q, Birckener J, Gourdou V, Nicolle C, Garnier M, Schwindenhammer V, Hannezo C, Aveline C, Cinotti R, Puisney B, Garot M, Chevalier S, Aubert JS, Wodey M, Lasocki S, Lecoeur S, Lagarrigue CJ, Li A, Faucher M, Foucher Y, Frasca D, Boisson M. Multicentre, double-blind, randomised controlled clinical trial comparing intermittent cefoxitin administration versus loading bolus followed by continuous infusion for the prevention of surgical site infection in colorectal surgery: the PROPHYLOXITIN study protocol. BMJ Open. 2025 Jan 28;15(1):e088306. doi: 10.1136/bmjopen-2024-088306.
PubMed 39880423
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Cefoxitin Administration Versus Loading Bolus Followed by Continuous Infusion for the Prevention of Surgical Site Infection in Colorectal Surgery: a Multicentre, Double-blind, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05755789
- Acronym / sponsor ID
- PROPHYLOXITIN / PROPHYLOXITIN
- Conditions
- Antibiotic Prophylaxis, Colorectal Surgery
- Keywords
- cefoxitin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 6 Mar 2023 (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.
The goal of this prospective, multicentre, double-blind, randomized clinical trial is to compare intermittent cefoxitin administration to loading bolus followed by continuous infusion for surgical antibiotic prophylaxis in colorectal surgery.
The main objective is to demonstrate the superiority of a loading dose of cefoxitin followed by continuous infusion over standard of care boluses in reducing SSI within 30 days after colorectal surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (innovative administration scheme) | Experimental | Drug: Loading bolus of cefoxitin, Drug: Continuous infusion of cefoxitin, Drug: Intermittent placeboContinuous infusion of cefoxitin + Intermittent placebo |
| Control group (recommended administration scheme) | Active comparator | Drug: Loading bolus of cefoxitin, Drug: Intermittent cefoxitin, Drug: Continuous infusion of placeboIntermittent cefoxitin + Continuous infusion of placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (≥18 years)
- Undergoing colorectal surgery (predictable duration > 90 min)
Key exclusion criteria (4 listed)
- Patients with known history of hypersensitivity to cefoxitin or others beta-lactams
- Patients with extreme severe obesity (defined by a body mass index greater than 50 kg/m2)
- Patients with severe renal insufficiency (clearance creatinine < 30ml/min)
- Active bacterial infection at the time of surgery or recent antimicrobial therapy (up to 2 weeks before surgery) except for oral surgical antibiotic prophylaxis
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 |
|---|---|---|
| Loading bolus of cefoxitinCefoxitin [2g] before incision | Drug | Control group (recommended administration scheme), Intervention group (innovative administration scheme) |
| Intermittent cefoxitinAdditional bolus of cefoxitin [1g] every 2 hours until the end of surgical closure | Drug | Control group (recommended administration scheme) |
| Continuous infusion of placeboContinuous infusion of placebo from the end of the loading bolus until the end of surgical closure | Drug | Control group (recommended administration scheme) |
| Continuous infusion of cefoxitinContinuous infusion of cefoxitin [0.5g/h] from the end of the loading bolus until the end of surgical closure | Drug | Intervention group (innovative administration scheme) |
| Intermittent placeboAdditional bolus of placebo every 2 hours until the end of surgical closure | Drug | Intervention group (innovative administration scheme) |
Primary outcome
Surgical site infection
Time frame: within 30 days after surgery
Proportion of patients with any surgical site infection according to the CDC criteria
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Derived from this study: PubMed 39880423Saint-Genis Q, Birckener J, Gourdou V, Nicolle C, Garnier M, Schwindenhammer V, Hannezo C, Aveline C, Cinotti R, Puisney B, Garot M, Chevalier S, Aubert JS, Wodey M, Lasocki S, Lecoeur S, Lagarrigue CJ, Li A, Faucher M, Foucher Y, Frasca D, Boisson M. Multicentre, double-blind, randomised controlled clinical trial comparing intermittent cefoxitin administration versus loading bolus followed by continuous infusion for the prevention of surgical site infection in colorectal surgery: the PROPHYLOXITIN study protocol. BMJ Open. 2025 Jan 28;15(1):e088306. doi: 10.1136/bmjopen-2024-088306.
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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. This study is not recruiting at the moment.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Loading bolus of cefoxitin, Intermittent cefoxitin and Continuous infusion of cefoxitin in people with Antibiotic Prophylaxis and Colorectal Surgery, run by Poitiers University Hospital at 19 sites 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthieu BOISSON, MD-PhD (+33549444635, matthieu.boisson@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infection (time frame: within 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05755789, which also lists 1 linked publication.
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 23 Apr 2024.