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OpenTrials
Completed

NCT Number: NCT03845790

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

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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Key information

Conditions

Surgical Site Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHU de Poitiers

Poitiers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood and microdialysis samples

Other

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

Primary outcomes

  1. Total and free plasma of vancomycin, clindamycin or gentamicin

    Time frame: 24 hours

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

    Time frame: 24 hours

  3. 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

  1. 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.

    Time frame: 2 days

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Feb 19, 2019
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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