Intermittent Cefoxitin Administration Versus Loading Bolus Followed by Continuous Infusion for the Prevention of Surgical Site Infection in Colorectal Surgery
PROPHYLOXITIN
1 other identifier
interventional
2,000
1 country
19
Brief 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. 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2023
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2023
CompletedFirst Posted
Study publicly available on registry
March 6, 2023
CompletedStudy Start
First participant enrolled
June 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedApril 23, 2024
April 1, 2024
1.9 years
February 23, 2023
April 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Surgical site infection
Proportion of patients with any surgical site infection according to the CDC criteria
within 30 days after surgery
Study Arms (2)
Intervention group (innovative administration scheme)
EXPERIMENTALContinuous infusion of cefoxitin + Intermittent placebo
Control group (recommended administration scheme)
ACTIVE COMPARATORIntermittent cefoxitin + Continuous infusion of placebo
Interventions
Cefoxitin \[2g\] before incision
Additional bolus of cefoxitin \[1g\] every 2 hours until the end of surgical closure
Continuous infusion of placebo from the end of the loading bolus until the end of surgical closure
Continuous infusion of cefoxitin \[0.5g/h\] from the end of the loading bolus until the end of surgical closure
Additional bolus of placebo every 2 hours until the end of surgical closure
Eligibility Criteria
You may qualify if:
- Adult patients (≥18 years)
- Undergoing colorectal surgery (predictable duration \> 90 min)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Centre Hospitalier de Poitiers
Poitiers, Vienne, 86021, France
CHU Angers
Angers, France
Hopital privé Arras les Bonnettes
Arras, France
CHU Caen
Caen, France
CHU Clermont Ferrand
Clermont-Ferrand, France
CHU Grenoble
Grenoble, France
Centre Léon Bérard
Lyon, France
Hospices Civils Lyon
Lyon, France
Institut Paoli Calmettes
Marseille, France
CHRU Nancy
Nancy, France
CHU de Nantes
Nantes, France
Hopital Européen Gorges Pompidou
Paris, France
Clinique Mutualiste la Sagesse
Rennes, France
Hôpital Privé Rennais Cesson Sevigné
Rennes, France
CH St Brieuc
Saint-Brieuc, France
CHU St Etienne
Saint-Etienne, France
Hopitaux de Strasbourg
Strasbourg, France
CHU Toulouse Rangueil
Toulouse, France
CH Bretagne Atlantique vannes
Vannes, France
Related Publications (1)
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.
PMID: 39880423DERIVED
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2023
First Posted
March 6, 2023
Study Start
June 22, 2023
Primary Completion
May 1, 2025
Study Completion
June 1, 2025
Last Updated
April 23, 2024
Record last verified: 2024-04