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

Poitiers University Hospital

Status and phase: Enrolling; Phase 3

Conditions: Colorectal Surgery; Antibiotic Prophylaxis

Treatments: Drug: Continuous infusion of cefoxitin; Drug: Intermittent placebo; Drug: Continuous infusion of placebo; Drug: Loading bolus of cefoxitin; Drug: Intermittent cefoxitin

Study type: Interventional

Funder types: Other

Identifiers

NCT05755789

PROPHYLOXITIN

Details and patient eligibility

About

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

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,000 participants in 2 patient groups

Intervention group (innovative administration scheme)

Experimental group

Description:

Continuous infusion of cefoxitin + Intermittent placebo

Treatment:

Drug: Intermittent placebo

Drug: Continuous infusion of cefoxitin

Drug: Loading bolus of cefoxitin

Control group (recommended administration scheme)

Active Comparator group

Description:

Intermittent cefoxitin + Continuous infusion of placebo

Treatment:

Drug: Continuous infusion of placebo

Drug: Loading bolus of cefoxitin

Drug: Intermittent cefoxitin