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

Last updated: April 19, 2024
Sponsor: Poitiers University Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Continuous infusion of cefoxitin

Intermittent placebo

Continuous infusion of placebo

Clinical Study ID

NCT05755789
PROPHYLOXITIN
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 50kg/m2)
  • Patients with severe renal insufficiency (clearance creatinine < 30ml/min)
  • Active bacterial infection at the time of surgery or recent antimicrobial therapy (upto 2 weeks before surgery) except for oral surgical antibiotic prophylaxis

Study Design

Total Participants: 2000
Treatment Group(s): 5
Primary Treatment: Continuous infusion of cefoxitin
Phase: 3
Study Start date:
June 22, 2023
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Centre Hospitalier de Poitiers

    Poitiers, Vienne 86021
    France

    Active - Recruiting

  • CHU Angers

    Angers,
    France

    Active - Recruiting

  • Hopital privé Arras les Bonnettes

    Arras,
    France

    Active - Recruiting

  • CHU Caen

    Caen,
    France

    Active - Recruiting

  • CHU Clermont Ferrand

    Clermont-Ferrand,
    France

    Active - Recruiting

  • CHU Grenoble

    Grenoble,
    France

    Active - Recruiting

  • Centre Léon Bérard

    Lyon,
    France

    Active - Recruiting

  • Hospices Civils Lyon

    Lyon,
    France

    Active - Recruiting

  • Institut Paoli Calmettes

    Marseille,
    France

    Active - Recruiting

  • CHRU Nancy

    Nancy,
    France

    Active - Recruiting

  • CHU de Nantes

    Nantes,
    France

    Active - Recruiting

  • Hopital Européen Gorges Pompidou

    Paris,
    France

    Active - Recruiting

  • Clinique Mutualiste la Sagesse

    Rennes,
    France

    Active - Recruiting

  • Hôpital Privé Rennais Cesson Sevigné

    Rennes,
    France

    Active - Recruiting

  • CH St Brieuc

    Saint-Brieuc,
    France

    Active - Recruiting

  • CHU St Etienne

    Saint-Étienne,
    France

    Active - Recruiting

  • Hopitaux de Strasbourg

    Strasbourg,
    France

    Active - Recruiting

  • CHU Toulouse Rangueil

    Toulouse,
    France

    Active - Recruiting

  • CH Bretagne Atlantique vannes

    Vannes,
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.