NCT03306290: CEFOBAR

Serum Concentration of CEFOxitin Used for Antibiotic Prophylaxis in Obese Patients Undergoing BARiatric Surgery

Completed NA Last updated 28 August 2018

What this trial tests

NA trial testing Serum dosage of antibiotic prophylaxis CEFOXITIN in Obese in 200 participants. Completed in 9 August 2018.

Timeline

30 October 2017

Primary endpoint
30 June 2018

9 August 2018

Quick facts

Lead sponsor	Central Hospital, Nancy, France
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	200
Start date	30 October 2017
Primary completion	30 June 2018
Estimated completion	9 August 2018
Sites	1 location across France

Drugs / interventions tested

• Serum dosage of antibiotic prophylaxis CEFOXITIN — full drug profile →

Conditions studied

• Obese — all drugs for Obese →
• Antibiotic Prophylaxis — all drugs for Antibiotic Prophylaxis →
• Bariatric Surgery Candidate — all drugs for Bariatric Surgery Candidate →

Sponsor

Central Hospital, Nancy, France

Who can join

18 and older, any sex, with Obese or Antibiotic Prophylaxis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Obesity is a pandemic problem in modern societies. Bariatric surgery (gastric by-pass and sleeve gastrectomy) has emerged as an efficient treatment to reduce morbidity and mortality related to obesity. Obesity and bariatric surgery are known to be risk factors of surgical site infections (SSI). The occurrence of SSI increases health cost and the duration of hospitalization. However, an appropriate antibiotic prophylaxis has been shown to reduce SSI. As recommended by several national societies, the antibiotic prophylaxis dose should be increased in the severely obese population. However, this recommendation lies on a low level of evidence. Besides, great disparities regarding obese patient antibiotic prophylaxis exist between countries and adequate doses are still not clearly defined. In France, for instance, the intravenous second generation cephalosporin CEFOXITIN is used for antibiotic prophylaxis in bariatric surgery at the initial loading dose of 4g (2-fold that of non-obese population) at the beginning of surgery.

Obese patients have increased risk of under-dosage due to modification of their pharmacokinetics (fat/lean mass, distribution volume, renal clearance, etc.). Only few studies, all investigating a low amount of patients, evaluated the appropriateness of intraoperative antibiotic prophylaxis dosage of different betalactam and cephalosporin in the obese population. This population was more likely to be under-dosed.

The aim of this study is to analyse the appropriateness of the reference dose of intravenous Cefoxitin used as antibiotic prophylaxis in severely obese patients undergoing bariatric surgery. This will be a 2-year prospective monocentric study held in the University Hospital of Nancy, France. A large group of obese patients (\~300) will be included. Serial serum concentration measurements of Cefoxitin will be performed before, during, and at skin closure of the bariatric surgery. This study will give insights in pharmacokinetics of the antibiotic prophylaxis in the obese population and will help to determine the initial dosage and the optimal method for antibiotic prophylaxis administration.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Population pharmacokinetics of prophylactic cefoxitin in elective bariatric surgery patients: a prospective monocentric study.
   Novy E, Liu X, Hernández-Mitre MP, Belveyre T, et al · · 2024 · cited 5× · PMID 38494157 · DOI 10.1016/j.accpm.2024.101376
2. Antibiotic prophylaxis with high-dose cefoxitin in bariatric surgery: an observational prospective single center study.
   Belveyre T, Guerci P, Pape E, Thilly N, et al · · 2019 · cited 2× · PMID 31591127 · DOI 10.1128/aac.01613-19