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

P

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

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

Trial contacts and locations

19

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Central trial contact

Nadia TEIXEIRA; Matthieu BOISSON, MD-PhD

Data sourced from clinicaltrials.gov

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