Pharmacokinetic Study of Vancomycin, Clindamycin And/or Gentamicin Administration During Surgery Using a Microdialysis Procedure

Poitiers University Hospital25 enrolled

Overview

The surgical site infection is one of the most important causes of postoperative morbidity. The appropriate antibiotic prophylaxis is one of the most effective way to prevent surgical site infections. The beta-lactam are the most frequent antibiotics recommended for surgical prophylaxis and patients known to be allergic to beta-lactam are more likely to presented surgical site infection, probably due to use of others antibiotic such as vancomycin or clindamycin. The main objective of the study is to describe the tissu and plasma pharmacokinetics of vancomycin, clindamycin and gentamicin using as surgical antibiotic prophylaxis in patients with beta-lactam hypersensivity and to predict the probability of target attainment for usual bacteria.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Surgical Site Infection

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patient between 18 and 80 years old * Patient with history of beta-lactam hypersensitivity * Patient who underwent abdominal or orthopedic surgery whose forseeable time exceeds 1 hour and requires a surgical antibiotic prophylaxis by vancomycin or clindamycin + gentamicin Exclusion Criteria: * morbid obesity (BMI \> 35 kg/m2) * mild to severe renal impairment (clearance creatinine \< 60 ml/min) * vancomycin, clindamycin or gentamicin hypersensitivity * pregnancy

Outcomes

Primary Outcomes

Total and free plasma of vancomycin, clindamycin or gentamicin

Time frame: 24 hours

Free tissue concentration of vancomycin, clindamycin or gentamicin every 20 minutes after the beginning of injections

Time frame: 24 hours

Probability of target attainment of PK/PD index for usual bacteria (AUC/CMI >1 for vancomycin and clindamycin, Cmax/CMI >8 for gentamicin) with the recommended dosing regimen

Time frame: 2 days

Secondary Outcomes

Probability of target attainment of PK/PD index for usual bacteria (AUC/CMI >1 for vancomycin and clindamycin, Cmax/CMI >8 for gentamicin) with new simulated dosing regimens.