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Trial record 46 of 231 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

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.


Condition or disease Intervention/treatment Phase
Surgical Site Infection Other: Blood and microdialysis samples Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pharmacokinetic study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pharmacokinetic Study of Vancomycin, Clindamycin and/or Gentamicin Administration During Surgery Using a Microdialysis Procedure
Actual Study Start Date : May 26, 2019
Estimated Primary Completion Date : September 26, 2020
Estimated Study Completion Date : September 26, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Blood and microdialysis samples
    Blood and microdialisys pharmacocinetic samples on one of the two antibiotics prescribed in routine use


Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03845790


Contacts
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Contact: Matthieu BOISSON 0033.549.442.517 Matthieu.BOISSON@chu-poitiers.fr
Contact: ARRACHE WASSILA 0033.549.443.903 Wassila.ARRACHE@chu-poitiers.fr

Locations
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France
CHU de Poitiers Recruiting
Poitiers, France
Contact: Matthieu Boisson, MD         
Sponsors and Collaborators
Poitiers University Hospital

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Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT03845790     History of Changes
Other Study ID Numbers: PK PROPHYLAXIE
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Vancomycin
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action