Clinical trial • Phase III • Other
CEFOXITIN SODIUM for Colorectal surgery
Phase III trial of CEFOXITIN SODIUM for Colorectal surgery.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Colorectal surgery
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 22-07-2024
- First CTIS Authorization Date
- 20-08-2024
Trial design
Randomised, control arm: loading bolus of cefoxitin 2 g followed by additional bolus of cefoxitin 1 g every 2 hours plus continuous infusion of placebo until end of surgical closure. intervention arm: loading bolus of cefoxitin 2 g followed by continuous infusion of cefoxitin 0.5 g/h plus additional boluses of placebo every 2 hours until end of surgical closure. Phase III trial across 21 sites in France.
- Randomised
- Yes
- Comparator
- Control arm: loading bolus of cefoxitin 2 g followed by additional bolus of cefoxitin 1 g every 2 hours plus continuous infusion of placebo until end of surgical closure. Intervention arm: loading bolus of cefoxitin 2 g followed by continuous infusion of cefoxitin 0.5 g/h plus additional boluses of placebo every 2 hours until end of surgical closure.
- Target Sample Size
- 2000
- Trial Duration For Participant
- 30
Eligibility
Recruits 2000 Persons benefiting from enhanced protection (namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection) are excluded. Inclusion requires the subject to be free (no guardianship/curatorship) and to have given their informed consent; minors are therefore not eligible..
- Pregnancy Exclusion
- Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy)
- Vulnerable Population
- Persons benefiting from enhanced protection (namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection) are excluded. Inclusion requires the subject to be free (no guardianship/curatorship) and to have given their informed consent; minors are therefore not eligible.
Inclusion criteria
- {"criterion_text":"- Adult patients (≥18 years)"}
- {"criterion_text":"- Undergoing colorectal surgery (predictable duration > 90 min)"}
- {"criterion_text":"- Patients benefiting from a Social Security system or benefiting from it through a third party"}
- {"criterion_text":"- Free subject, without guardianship or curatorship or subordination"}
- {"criterion_text":"- Having given their informed consent"}
Exclusion criteria
- {"criterion_text":"- Patients with known history of hypersensitivity to cefoxitin or others beta-lactams"}
- {"criterion_text":"- Patients with extreme severe obesity (defined by a body mass index greater than 50 kg/m2)"}
- {"criterion_text":"- Patients with severe renal insufficiency (clearance creatinine < 30ml/min)"}
- {"criterion_text":"- Active bacterial infection at the time of surgery or recent antimicrobial therapy (up to 2 weeks before surgery) except for oral surgical antibiotic prophylaxis"}
- {"criterion_text":"- Participation to another clinical trial aimed at reducing SSI"}
- {"criterion_text":"- Patients already previously enrolled in this study"}
- {"criterion_text":"- Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy)"}
- {"criterion_text":"- Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Proportion of patients with any SSI within 30 days after surgery.","definition_or_measurement_approach":"Measured as the proportion of patients with any surgical site infection (SSI) occurring within 30 days after surgery."}
Secondary endpoints
- {"endpoint_text":"- Proportion of patients with each type of SSI (superficial, deep and/or organ–space infection)","definition_or_measurement_approach":"Measured as the proportion of patients with each SSI type (superficial, deep, organ-space)."}
- {"endpoint_text":"- Proportion of patients with surgical reintervention","definition_or_measurement_approach":"Measured as the proportion of patients undergoing surgical reintervention."}
- {"endpoint_text":"- Proportion of patients with anastomotic leak","definition_or_measurement_approach":"Measured as the proportion of patients with anastomotic leak."}
- {"endpoint_text":"- Proportion of patients with postoperative complication according to the Dindo and Clavien classification","definition_or_measurement_approach":"Measured as the proportion of patients with postoperative complications classified by the Dindo-Clavien system."}
- {"endpoint_text":"- Proportion of patients with Clostridium difficile infection","definition_or_measurement_approach":"Measured as the proportion of patients diagnosed with Clostridium difficile infection."}
- {"endpoint_text":"- Hospital readmission censored at day 30","definition_or_measurement_approach":"Measured as hospital readmission censored at 30 days after surgery."}
- {"endpoint_text":"- Unexpected admission to the ICU censored at day 30","definition_or_measurement_approach":"Measured as unexpected ICU admission censored at 30 days after surgery."}
- {"endpoint_text":"- Duration of hospital stay and hospital free days","definition_or_measurement_approach":"Measured as length of hospital stay and hospital-free days, censored at day 30 after surgery."}
- {"endpoint_text":"- All-causes mortality","definition_or_measurement_approach":"Measured as all-cause mortality (timeframe aligned with study follow-up, primary endpoint 30 days)."}
- {"endpoint_text":"- Proportion of per operative adverse events","definition_or_measurement_approach":"Measured as the proportion of patients experiencing peri-operative adverse events."}
Recruitment
- Planned Sample Size
- 2000
- Recruitment Window Months
- 51
- Consent Approach
- Informed consent must be provided by the participant themselves; subjects must be free (no guardianship/curatorship) and have given informed consent. Minors and adults under legal protection are excluded. Subject information and consent forms (L1_SIS and related documents) are provided (documents include French translations).
Geography
- Total Number Of Sites
- 21
- Total Number Of Participants
- 2000
France
- Latest Decision Or Authorization Date
- 23-01-2026
- Number Of Sites
- 21
- Number Of Participants
- 2000
Sites
- Site Name
- Hôpital Privé Arras Les Bonnettes
- Department Name
- Anesthésie-Réanimation
- Principal Investigator Name
- Matthias GAROT
- Principal Investigator Email
- m.garot@ramsaygds.fr
- Contact Person Name
- Matthias GAROT
- Contact Person Email
- m.garot@ramsaygds.fr
- Site Name
- Clinique Pasteur
- Department Name
- Anesthésie-Réanimation
- Principal Investigator Name
- Ségolène MROZEK
- Principal Investigator Email
- smrozek@clinique-pasteur.com
- Contact Person Name
- Ségolène MROZEK
- Contact Person Email
- smrozek@clinique-pasteur.com
- Site Name
- Centre Hospitalier Bretagne Atlantique
- Department Name
- Réanimation Polyvalente
- Principal Investigator Name
- Benjamin PUISNEY
- Principal Investigator Email
- benjamin.puisney@ch-bretagne-atlantique.fr
- Contact Person Name
- Benjamin PUISNEY
- Contact Person Email
- benjamin.puisney@ch-bretagne-atlantique.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Anesthésie Réanimation
- Principal Investigator Name
- Raphaël CINOTTI
- Principal Investigator Email
- raphael.cinotti@chu-nantes.fr
- Contact Person Name
- Raphaël CINOTTI
- Contact Person Email
- raphael.cinotti@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Anesthésie et Réanimation
- Principal Investigator Name
- Victor SCHWINDENHAMMER
- Principal Investigator Email
- vschwindenhammer@chu-grenoble.fr
- Contact Person Name
- Victor SCHWINDENHAMMER
- Contact Person Email
- vschwindenhammer@chu-grenoble.fr
- Site Name
- Groupe Hospitalier Bretagne Sud
- Department Name
- Anesthésie-Réanimation
- Principal Investigator Name
- Jeanne COSSIC
- Principal Investigator Email
- j.coissic@ghbs.bzh
- Contact Person Name
- Jeanne COSSIC
- Contact Person Email
- j.coissic@ghbs.bzh
- Site Name
- Institut Paoli Calmettes
- Department Name
- Unité Fonctionnelle d'Anesthésie
- Principal Investigator Name
- Marion FAUCHER
- Principal Investigator Email
- FAUCHERM@ipc.unicancer.fr
- Contact Person Name
- Marion FAUCHER
- Contact Person Email
- FAUCHERM@ipc.unicancer.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Service d'Anesthésie-Réanimation et Médecine Péri-Opératoire
- Principal Investigator Name
- Matthieu BOISSON
- Principal Investigator Email
- matthieu.boisson@chu-poitiers.fr
- Contact Person Name
- Matthieu BOISSON
- Contact Person Email
- matthieu.boisson@chu-poitiers.fr
- Site Name
- Centre Leon Berard
- Department Name
- Anesthésie-Réanimation
- Principal Investigator Name
- Cécile HANNEZO
- Principal Investigator Email
- cecile.hannezo@lyon.unicancer.fr
- Contact Person Name
- Cécile HANNEZO
- Contact Person Email
- cecile.hannezo@lyon.unicancer.fr
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- Anesthésie, Réanimation et Médecine Périopératoire
- Principal Investigator Name
- Marc GARNIER
- Principal Investigator Email
- mgarnier@chu-clermontferrand.fr
- Contact Person Name
- Marc GARNIER
- Contact Person Email
- mgarnier@chu-clermontferrand.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Anesthésie Réanimation
- Principal Investigator Name
- Guillaume PORTA BONETE
- Principal Investigator Email
- porta-bonete.g@chu-toulouse.fr
- Contact Person Name
- Guillaume PORTA BONETE
- Contact Person Email
- porta-bonete.g@chu-toulouse.fr
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- Anesthésie-Réanimation
- Principal Investigator Name
- Maxime WODEY
- Principal Investigator Email
- maxime.wodey@chu-st-etienne.fr
- Contact Person Name
- Maxime WODEY
- Contact Person Email
- maxime.wodey@chu-st-etienne.fr
- Site Name
- Centre Hospitalier De Saint-Brieuc
- Department Name
- Anesthésie
- Principal Investigator Name
- Sylvain LECOEUR
- Principal Investigator Email
- sylvain.lecoeur@armorsante.bzh
- Contact Person Name
- Sylvain LECOEUR
- Contact Person Email
- sylvain.lecoeur@armorsante.bzh
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Anesthésie-Réanimation
- Principal Investigator Name
- Jean-Sébastien AUBERT
- Principal Investigator Email
- jean-sebastien.aubert@aphp.fr
- Contact Person Name
- Jean-Sébastien AUBERT
- Contact Person Email
- jean-sebastien.aubert@aphp.fr
- Site Name
- CHRU De Nancy
- Department Name
- Anesthésie-Réanimation
- Principal Investigator Name
- Julien BIRCKENER
- Principal Investigator Email
- j.birckener@chru-nancy.fr
- Contact Person Name
- Julien BIRCKENER
- Contact Person Email
- j.birckener@chru-nancy.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Anesthésie
- Principal Investigator Name
- Anne LI
- Principal Investigator Email
- anne.li@chu-lyon.fr
- Contact Person Name
- Anne LI
- Contact Person Email
- anne.li@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Caen Normandie
- Department Name
- Anesthésie Réanimation
- Principal Investigator Name
- Anne-Lise FIANT
- Principal Investigator Email
- fiant-al@chu-caen.fr
- Contact Person Name
- Anne-Lise FIANT
- Contact Person Email
- fiant-al@chu-caen.fr
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Department Name
- Anesthésie Réanimation
- Principal Investigator Name
- Sigismond LASOCKI
- Principal Investigator Email
- silasocki@chu-angers.fr
- Contact Person Name
- Sigismond LASOCKI
- Contact Person Email
- silasocki@chu-angers.fr
- Site Name
- Hopital Prive Sevigne
- Department Name
- Anesthésie-Réanimation
- Principal Investigator Name
- Christophe AVELINE
- Principal Investigator Email
- caveline@vivalto-sante.com
- Contact Person Name
- Christophe AVELINE
- Contact Person Email
- caveline@vivalto-sante.com
- Site Name
- Centre Hospitalier De Pau
- Department Name
- Anesthésie
- Principal Investigator Name
- Pierre-Marie SAULAIS
- Principal Investigator Email
- Pierre-Marie.SAULAIS@ch-pau.fr
- Contact Person Name
- Pierre-Marie SAULAIS
- Contact Person Email
- Pierre-Marie.SAULAIS@ch-pau.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Réanimation Chirurgicale Polyvalente
- Principal Investigator Name
- Charles LAGARRIGUE
- Principal Investigator Email
- charles.lagarrigue@chru-strasbourg.fr
- Contact Person Name
- Charles LAGARRIGUE
- Contact Person Email
- charles.lagarrigue@chru-strasbourg.fr
Sponsor
Primary sponsor
- Full Name
- Centre Hospitalier Universitaire De Poitiers
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- CEFOXITINE PANPHARMA 1 g, poudre pour solution injectable (IV)
- Active Substance
- CEFOXITIN SODIUM
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- Intravenous
- Authorisation Status
- Authorised
- Starting Dose
- Loading bolus 2 g
- Dose Levels
- Loading bolus 2 g; continuous infusion 0.5 g/h; additional bolus 1 g every 2 hours (control arm); product max daily dose 4 g
- Frequency
- Continuous infusion 0.5 g/h; bolus doses as specified (additional bolus every 2 hours)
- Maximum Dose
- 4 g
- Investigational Product Name
- CHLORURE DE SODIUM 0,9 % AGUETTANT, solution pour perfusion
- Active Substance
- SODIUM CHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- Intravenous
- Authorisation Status
- Authorised
- Starting Dose
- Placebo infusion (sodium chloride 0.9%) as per arm schedule
- Dose Levels
- Placebo infusion volumes up to product max (100 ml noted in product record)
- Frequency
- As required to match active infusion schedule
- Maximum Dose
- 100 ml (product maxTotalDoseAmount as provided)
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