Informations générales (source: ClinicalTrials.gov)
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 (PROPHYLOXITIN)
Interventional
Phase 3
Poitiers University Hospital (Voir sur ClinicalTrials)
juin 2023
juin 2025
29 juin 2024
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
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Europeen Georges Pompidou | Jean Sebastien AUBERT, Pr | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier de Poitiers - 86021 - Poitiers - Vienne - France | Matthieu BOISSON, PU-PH | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - Lyon - France | Cécile HANNEZO, Dr | Contact (sur clinicalTrials) | |||
| CH Bretagne Atlantique vannes - Vannes - France | Benjamin PUISNEY, Dr | Contact (sur clinicalTrials) | |||
| CH St Brieuc - Saint-Brieuc - France | Sylvain LECOEUR, Dr | Contact (sur clinicalTrials) | |||
| CHRU Nancy - Nancy - France | Julien BIRCKENER, Dr | Contact (sur clinicalTrials) | |||
| CHU Angers - Angers - France | Sigismond Lasocki, Pr | Contact (sur clinicalTrials) | |||
| CHU Caen - Caen - France | Claire NICOLLE, Dr | Contact (sur clinicalTrials) | |||
| CHU Clermont Ferrand - Clermont-Ferrand - France | Marc GARNIER, Dr | Contact (sur clinicalTrials) | |||
| CHU de Nantes - Nantes - France | Raphael CINOTTI, Pr | Contact (sur clinicalTrials) | |||
| CHU Grenoble - Grenoble - France | Victor Schwindenhammer, Dr | Contact (sur clinicalTrials) | |||
| CHU St Etienne - Saint-Étienne - France | Maxime WODEY, Dr | Contact (sur clinicalTrials) | |||
| CHU Toulouse Rangueil - Toulouse - France | Guillaume PORTA BONETE, Dr | Contact (sur clinicalTrials) | |||
| Clinique Mutualiste la Sagesse - Rennes - France | Stéphanie CHEVALIER, Dr | Contact (sur clinicalTrials) | |||
| Hopital privé Arras les Bonnettes - Arras - France | Matthias GAROT, Dr | Contact (sur clinicalTrials) | |||
| Hôpital Privé Rennais Cesson Sevigné - Rennes - France | Christophe AVELINE, Dr | Contact (sur clinicalTrials) | |||
| Hopitaux de Strasbourg - Strasbourg - France | Charles LAGARRIGUE, Dr | Contact (sur clinicalTrials) | |||
| Hospices Civils Lyon - Lyon - France | Anne LI, Dr | Contact (sur clinicalTrials) | |||
| Institut Paoli Calmettes - Marseille - France | Marion FAUCHER, Dr | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Adult patients (≥18 years)
- Undergoing colorectal surgery (predictable duration > 90 min)
- Adult patients (≥18 years)
- Undergoing colorectal surgery (predictable duration > 90 min)
- 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