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

Colorectal Surgery Clinical Trial

— PROPHYLOXITIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05755789
• Other study ID #: PROPHYLOXITIN
• Status: Recruiting
• Phase: Phase 3
• Start date: June 22, 2023
• Est. completion date: June 2025

Study information

• Verified date: April 2024
• Source: Poitiers University Hospital
• Contact: Matthieu BOISSON, MD-PhD
• Phone: +33549444635
• Email: matthieu.boisson[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: June 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Prophylaxis
• Colorectal Surgery
• Surgical Wound Infection

Intervention

Drug:
• Loading bolus of cefoxitin
Cefoxitin [2g] before incision
• Intermittent cefoxitin
Additional bolus of cefoxitin [1g] every 2 hours until the end of surgical closure
• Continuous infusion of placebo
Continuous infusion of placebo from the end of the loading bolus until the end of surgical closure
• Continuous infusion of cefoxitin
Continuous infusion of cefoxitin [0.5g/h] from the end of the loading bolus until the end of surgical closure
• Intermittent placebo
Additional bolus of placebo every 2 hours until the end of surgical closure

Locations

Country	Name	City	State
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	Centre Hospitalier de Poitiers	Poitiers	Vienne
France	Clinique Mutualiste la Sagesse	Rennes
France	Hôpital Privé Rennais Cesson Sevigné	Rennes
France	CH St Brieuc	Saint-Brieuc
France	CHU St Etienne	Saint-Étienne
France	Hopitaux de Strasbourg	Strasbourg
France	CHU Toulouse Rangueil	Toulouse
France	CH Bretagne Atlantique vannes	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection	Proportion of patients with any surgical site infection according to the CDC criteria	within 30 days after surgery