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Trial record 46 of 234 for:    clindamycin

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

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ClinicalTrials.gov Identifier: NCT03845790
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

Tracking Information
First Submitted Date  ICMJE February 15, 2019
First Posted Date  ICMJE February 19, 2019
Last Update Posted Date June 13, 2019
Actual Study Start Date  ICMJE May 26, 2019
Estimated Primary Completion Date September 26, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2019)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03845790 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2019)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic Study of Vancomycin, Clindamycin and/or Gentamicin Administration During Surgery Using a Microdialysis Procedure
Official Title  ICMJE Pharmacokinetic Study of Vancomycin, Clindamycin and/or Gentamicin Administration During Surgery Using a Microdialysis Procedure
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Pharmacokinetic study
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Surgical Site Infection
Intervention  ICMJE Other: Blood and microdialysis samples
Blood and microdialisys pharmacocinetic samples on one of the two antibiotics prescribed in routine use
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 15, 2019)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 26, 2020
Estimated Primary Completion Date September 26, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 3 hours 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Matthieu BOISSON 0033.549.442.517 Matthieu.BOISSON@chu-poitiers.fr
Contact: ARRACHE WASSILA 0033.549.443.903 Wassila.ARRACHE@chu-poitiers.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03845790
Other Study ID Numbers  ICMJE PK PROPHYLAXIE
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Poitiers University Hospital
Study Sponsor  ICMJE Poitiers University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Poitiers University Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP