Comparing two methods of cefoxitin administration to prevent infections after colorectal surgery

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

This study is testing two different ways of giving cefoxitin to see which one better prevents infections after colorectal surgery for adults.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Poitiers University Hospital (Academic / other)
• Locations: 19 sites (Poitiers, Vienne and 18 other locations)
• Trial ID: NCT05755789 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of intermittent cefoxitin administration versus a loading bolus followed by continuous infusion for preventing surgical site infections (SSI) in patients undergoing colorectal surgery. It is a multicenter, double-blind, randomized study that will assess which method better reduces the incidence of SSI within 30 days post-surgery. The trial will involve adult patients who are scheduled for colorectal procedures lasting more than 90 minutes and will compare the outcomes of different cefoxitin administration strategies.

Who should consider this trial

Good fit: Ideal candidates for this study are adult patients aged 18 and older who are scheduled for colorectal surgery with a predictable duration of more than 90 minutes.

Not a fit: Patients with a known hypersensitivity to cefoxitin or other beta-lactams, severe obesity, severe renal insufficiency, or active bacterial infections at the time of surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved protocols for antibiotic prophylaxis, potentially reducing the risk of infections after colorectal surgeries.

How similar studies have performed: Other studies have explored various antibiotic prophylaxis methods, but this specific comparison of intermittent versus continuous infusion of cefoxitin is novel.

Eligibility criteria

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

Where this trial is running

Poitiers, Vienne and 18 other locations

• Centre Hospitalier de Poitiers — Poitiers, Vienne, France (Recruiting)
• CHU Angers — Angers, France (Recruiting)
• Hopital privé Arras les Bonnettes — Arras, France (Recruiting)
• CHU Caen — Caen, France (Recruiting)
• CHU Clermont Ferrand — Clermont-Ferrand, France (Recruiting)
• CHU Grenoble — Grenoble, France (Recruiting)
• Centre Léon Bérard — Lyon, France (Recruiting)
• Hospices Civils Lyon — Lyon, France (Recruiting)
• Institut Paoli Calmettes — Marseille, France (Recruiting)
• CHRU Nancy — Nancy, France (Recruiting)
• CHU de Nantes — Nantes, France (Recruiting)
• Hopital Européen Gorges Pompidou — Paris, France (Recruiting)
• Clinique Mutualiste la Sagesse — Rennes, France (Recruiting)
• Hôpital Privé Rennais Cesson Sevigné — Rennes, France (Recruiting)
• CH St Brieuc — Saint-Brieuc, France (Recruiting)
• CHU St Etienne — Saint-Étienne, France (Recruiting)
• Hopitaux de Strasbourg — Strasbourg, France (Recruiting)
• CHU Toulouse Rangueil — Toulouse, France (Recruiting)
• CH Bretagne Atlantique vannes — Vannes, France (Recruiting)

Study contacts

• Study coordinator: Matthieu BOISSON, MD-PhD

Conditions Antibiotic Prophylaxis; Colorectal Surgery; cefoxitin