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

Primary Purpose

Surgical Site Infection

Status
Recruiting
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Blood and microdialysis samples
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Surgical Site Infection

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de PoitiersRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
February 15, 2019
Last Updated
January 12, 2023
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03845790
Brief Title
Pharmacokinetic Study of Vancomycin, Clindamycin and/or Gentamicin Administration During Surgery Using a Microdialysis Procedure
Official Title
Pharmacokinetic Study of Vancomycin, Clindamycin and/or Gentamicin Administration During Surgery Using a Microdialysis Procedure
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2019 (Actual)
Primary Completion Date
November 26, 2023 (Anticipated)
Study Completion Date
November 26, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Pharmacokinetic study
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Blood and microdialysis samples
Intervention Description
Blood and microdialisys pharmacocinetic samples on one of the two antibiotics prescribed in routine use
Primary Outcome Measure Information:
Title
Total and free plasma of vancomycin, clindamycin or gentamicin
Time Frame
24 hours
Title
Free tissue concentration of vancomycin, clindamycin or gentamicin every 20 minutes after the beginning of injections
Time Frame
24 hours
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthieu BOISSON
Phone
0033.549.442.517
Email
Matthieu.BOISSON@chu-poitiers.fr
Facility Information:
Facility Name
CHU de Poitiers
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthieu Boisson, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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