Intermittent Cefoxitin Administration Versus Loading Bolus Followed by Continuous Infusion for the Prevention of Surgical Site Infection in Colorectal Surgery (PROPHYLOXITIN)

April 19, 2024 updated by: Poitiers University Hospital

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

2000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France
        • Recruiting
        • Chu Angers
        • Contact:
          • Sigismond Lasocki, Pr
      • Arras, France
        • Recruiting
        • Hopital privé Arras les Bonnettes
        • Contact:
          • Matthias GAROT, Dr
      • Caen, France
        • Recruiting
        • CHU caen
        • Contact:
          • Claire NICOLLE, Dr
      • Clermont-Ferrand, France
        • Recruiting
        • CHU Clermont Ferrand
        • Contact:
          • Marc GARNIER, Dr
      • Grenoble, France
        • Recruiting
        • CHU Grenoble
        • Contact:
          • Victor Schwindenhammer, Dr
      • Lyon, France
        • Recruiting
        • Centre LEON BERARD
        • Contact:
          • Cécile HANNEZO, Dr
      • Lyon, France
        • Recruiting
        • Hospices Civils Lyon
        • Contact:
          • Anne LI, Dr
      • Marseille, France
        • Recruiting
        • Institut Paoli Calmettes
        • Contact:
          • Marion FAUCHER, Dr
      • Nancy, France
        • Recruiting
        • CHRU Nancy
        • Contact:
          • Julien BIRCKENER, Dr
      • Nantes, France
        • Recruiting
        • CHU de Nantes
        • Contact:
          • Raphael CINOTTI, Pr
      • Paris, France
        • Recruiting
        • Hopital Européen Gorges Pompidou
        • Contact:
          • Jean Sebastien AUBERT, Pr
      • Rennes, France
        • Recruiting
        • Clinique Mutualiste la Sagesse
        • Contact:
          • Stéphanie CHEVALIER, Dr
      • Rennes, France
        • Recruiting
        • Hôpital Privé Rennais Cesson Sevigné
        • Contact:
          • Christophe AVELINE, Dr
      • Saint-Brieuc, France
        • Recruiting
        • CH St Brieuc
        • Contact:
          • Sylvain LECOEUR, Dr
      • Saint-Étienne, France
        • Recruiting
        • CHU St Etienne
        • Contact:
          • Maxime WODEY, Dr
      • Strasbourg, France
        • Recruiting
        • Hopitaux de Strasbourg
        • Contact:
          • Charles LAGARRIGUE, Dr
      • Toulouse, France
        • Recruiting
        • CHU Toulouse Rangueil
        • Contact:
          • Guillaume PORTA BONETE, Dr
      • Vannes, France
        • Recruiting
        • CH Bretagne Atlantique vannes
        • Contact:
          • Benjamin PUISNEY, Dr
    • Vienne
      • Poitiers, Vienne, France, 86021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients (≥18 years)
  • Undergoing colorectal surgery (predictable duration > 90 min)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group (innovative administration scheme)
Continuous infusion of cefoxitin + Intermittent placebo
Drug: Continuous infusion of cefoxitin
Continuous infusion of cefoxitin [0.5g/h] from the end of the loading bolus until the end of surgical closure
Drug: Intermittent placebo
Additional bolus of placebo every 2 hours until the end of surgical closure
Drug: Loading bolus of cefoxitin
Cefoxitin [2g] before incision
Active Comparator: Control group (recommended administration scheme)
Intermittent cefoxitin + Continuous infusion of placebo
Drug: Intermittent cefoxitin
Additional bolus of cefoxitin [1g] every 2 hours until the end of surgical closure
Drug: Continuous infusion of placebo
Continuous infusion of placebo from the end of the loading bolus until the end of surgical closure
Drug: Loading bolus of cefoxitin
Cefoxitin [2g] before incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical site infection
Time Frame: within 30 days after surgery
Proportion of patients with any surgical site infection according to the CDC criteria
within 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2023

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

February 23, 2023

First Posted (Actual)

March 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROPHYLOXITIN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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