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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-26

Study Completion Date

2024-09-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Surgical Site Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pharmacokinetic study

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Interventions

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Blood and microdialysis samples

Blood and microdialisys pharmacocinetic samples on one of the two antibiotics prescribed in routine use

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No