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

Phase 3

Recruiting

• Conditions: Colorectal Surgery; Antibiotic Prophylaxis
• Interventions: Drug: Loading bolus of cefoxitin; Drug: Intermittent cefoxitin; Drug: Continuous infusion of cefoxitin; Drug: Intermittent placebo; Drug: Continuous infusion of placebo

• Registration Number: NCT05755789
• Lead Sponsor: Poitiers University Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-23
• Study First Submitted QC: 2023-02-23
• Study First Posted: 2023-03-06
• Study Start: 2023-06-22
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-23
• Primary Completion: 2025-05
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group (recommended administration scheme)	Loading bolus of cefoxitin	Intermittent cefoxitin + Continuous infusion of placebo
Intervention group (innovative administration scheme)	Intermittent placebo	Continuous infusion of cefoxitin + Intermittent placebo
Control group (recommended administration scheme)	Intermittent cefoxitin	Intermittent cefoxitin + Continuous infusion of placebo
Intervention group (innovative administration scheme)	Loading bolus of cefoxitin	Continuous infusion of cefoxitin + Intermittent placebo
Intervention group (innovative administration scheme)	Continuous infusion of cefoxitin	Continuous infusion of cefoxitin + Intermittent placebo
Control group (recommended administration scheme)	Continuous infusion of placebo	Intermittent cefoxitin + Continuous infusion of placebo

Primary Outcome Measures

Name	Time	Method
Surgical site infection	within 30 days after surgery	Proportion of patients with any surgical site infection according to the CDC criteria

Trial Locations

Locations (19)

CHU Angers; 🇫🇷 Angers, France

CHU Clermont Ferrand; 🇫🇷 Clermont-Ferrand, France

Hopital privé Arras les Bonnettes; 🇫🇷 Arras, France

CHU Grenoble; 🇫🇷 Grenoble, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Hospices Civils Lyon; 🇫🇷 Lyon, France

CHRU Nancy; 🇫🇷 Nancy, France

Institut Paoli Calmettes; 🇫🇷 Marseille, France

CHU de Nantes; 🇫🇷 Nantes, France

Hôpital Privé Rennais Cesson Sevigné; 🇫🇷 Rennes, France

Hopital Européen Gorges Pompidou; 🇫🇷 Paris, France

Clinique Mutualiste la Sagesse; 🇫🇷 Rennes, France

CH St Brieuc; 🇫🇷 Saint-Brieuc, France

CHU St Etienne; 🇫🇷 Saint-Étienne, France

CH Bretagne Atlantique vannes; 🇫🇷 Vannes, France

CHU Toulouse Rangueil; 🇫🇷 Toulouse, France

Hopitaux de Strasbourg; 🇫🇷 Strasbourg, France

Centre Hospitalier de Poitiers; 🇫🇷 Poitiers, Vienne, France

CHU Caen; 🇫🇷 Caen, France