Clinical trial NCT02703857: Study of Repeated Cefoxitin Administration in Major Abdominal Surgery Using a Microdialysis Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Antibiotic Prophylaxis Surgery
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The surgical site infection is one of the most important causes of postoperative morbidity. The appropriate antibiotic prophylaxis is one of the most effective ways to prevent surgical site infections. The recommendations of the French Society of Anesthesia Resuscitation on antibiotic prophylaxis in long surgeries are based on low documentation, including frequency and dosage of reinjection.

The main objective of the study is to describe the tissue and plasma pharmacokinetics of cefoxitin after repeated injections.

This is an open monocentric study (phase 4) including adults aged 18 to 80 years in need of major abdominal surgery whose foreseeable time exceeds 4 hours and justifying an antibiotic prophylaxis by cefoxitin.

They receive 2 g cefoxitin parenterally at least 30 minutes before the incision and then every 2 hours until closing.

The primary endpoints are:

* Total and plasma free concentrations of cefoxitin 0, 10, 30, 60, 90, 120 minutes after start of each infusion cefoxitin
* Tissue free concentrations of cefoxitin every 20 minutes after the start of the first infusion cefoxitin until skin closure
* Urinary concentrations of cefoxitin


Eligibility criteria: Inclusion Criteria:

* Patients who underwent major abdominal surgery whose forseeable time exceeds 4 hours and requires an antibiotic prophylaxis by cefoxitin

Exclusion Criteria:

* morbid obesity (BMI \> 35 kg/m²)
* severe renal impairment (clearance creatinine \< 30ml/min)
* beta lactam hypersensitivity
* pregnancy

Primary outcomes:
measure: Total and free plasma of cefoxitin after repeated injections
timeFrame: 48 hours
measure: Free tissue concentration of cefoxitin every 20 minutes after the beginning of injections
timeFrame: 48 hours
measure: Concentration of cefoxitin in urine after every injection
timeFrame: 48 hours
Secondary outcomes:
measure: Percentage of time when tissue concentration of cefoxitin is higher than the minimal inhibitory concentration of target organisms
timeFrame: 48 hours
measure: Concentrations of antibiotic in peritoneal fluid
timeFrame: 48 hours
measure: Clearance of distribution of cefoxitin
timeFrame: 48 hours
measure: Clearance of elimination of cefoxitin
timeFrame: 48 hours
measure: Cmax of Cefoxitin
timeFrame: 48 hours
measure: Vd of distribution o cefoxitin
timeFrame: 48 hours
measure: Area under the curve of plasma and tissue concentration of cefoxitin
timeFrame: 48 hours
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Centre Hospitalier de Poitiers
Study officials:
References:
citation: Boisson M, Torres BGS, Yani S, Couet W, Mimoz O, Dahyot-Fizelier C, Marchand S, Gregoire N. Reassessing the dosing of cefoxitin prophylaxis during major abdominal surgery: insights from microdialysis and population pharmacokinetic modelling. J Antimicrob Chemother. 2019 Jul 1;74(7):1975-1983. doi: 10.1093/jac/dkz139.