Clinical trial NCT05755789: Intermittent Cefoxitin Administration Versus Loading Bolus Followed by Continuous Infusion for the Prevention of Surgical Site Infection in Colorectal Surgery
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Antibiotic Prophylaxis
Colorectal Surgery
Keywords: cefoxitin
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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

Primary outcomes:
measure: Surgical site infection
timeFrame: within 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Centre Hospitalier de Poitiers
state: Vienne
city: Angers
country: France
facility: CHU Angers
city: Arras
country: France
facility: Hopital privé Arras les Bonnettes
city: Caen
country: France
facility: CHU Caen
city: Clermont-Ferrand
country: France
facility: CHU Clermont Ferrand
city: Grenoble
country: France
facility: CHU Grenoble
city: Lyon
country: France
facility: Centre Léon Bérard
city: Lyon
country: France
facility: Hospices Civils Lyon
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Nancy
country: France
facility: CHRU Nancy
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: Hopital Européen Gorges Pompidou
city: Rennes
country: France
facility: Clinique Mutualiste la Sagesse
city: Rennes
country: France
facility: Hôpital Privé Rennais Cesson Sevigné
city: Saint-Brieuc
country: France
facility: CH St Brieuc
city: Saint-Étienne
country: France
facility: CHU St Etienne
city: Strasbourg
country: France
facility: Hopitaux de Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse Rangueil
city: Vannes
country: France
facility: CH Bretagne Atlantique vannes
Study officials:
References: