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Trial record 24 of 47 for:    "Prosthetic Joint Infection"

Comparison of Two Empirical Antimicrobial Therapies of Prosthetic Joint Infection

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ClinicalTrials.gov Identifier: NCT03850860
Recruitment Status : Recruiting
First Posted : February 22, 2019
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Eugénie MABRUT, Hospices Civils de Lyon

Brief Summary:
The empirical use of vancomycin in combination with a broad-spectrum beta-lactam is currently recommended after the initial surgery of prosthetic joint infection (PJI). However, the tolerability of such high-dose intravenous regimens is poorly known. T

Condition or disease Intervention/treatment
Bone and Joint Infection Other: empirical antibiotherapy

Detailed Description:
The empirical use of vancomycin in combination with a broad-spectrum beta-lactam is currently recommended after the initial surgery of prosthetic joint infection (PJI). However, the tolerability of such high-dose intravenous regimens is poorly known. The empirical antimicrobial therapy of PJI is associated with an important rate of adverse, linked with the use of the vancomycin and the piperacillin-tazobactam combination. Some studies suggest to use vancomycin-cefepime, which remains to be evaluated in PJI.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Comparison of the Tolerance of Vancomycin in Combination With Piperacillin/Tazobactam or Cefepim as Empirical Antimicrobial Therapy of Prosthetic Joint Infection
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
empirical antibotherapy currently used
patients having had a vancomycin and piperacillin-tazobactam combination as empirical antibiotherapy
Other: empirical antibiotherapy
comparison of the outcome in the 2 groups having had 2 different empirical antibiotherapies

another empirical antibotherapy
patients having had a vancomycin and cefepime combination as empirical antibiotherapy
Other: empirical antibiotherapy
comparison of the outcome in the 2 groups having had 2 different empirical antibiotherapies




Primary Outcome Measures :
  1. Rate of Treatment Failure [ Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption ]
    Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin


Secondary Outcome Measures :
  1. rate of adverse events [ Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption ]
    Description of adverses events leading to stop the empirical treatment

  2. rate of bacteria responsible for infection [ Time Frame: Outcome is measured at the end of follow-up (usually between 12 and 24 months after antibiotic therapy disruption ]
    bacterial epidemiology



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
patients having had a prosthetic joint infection and having had a postoperative empirical antibiotherapy with combination of vancomycine and piperacillin-tazobactam or vancomycine and cefepime manage at the croix rousse hospital
Criteria

Inclusion Criteria:

  • patients having had a prosthetic joint infection and having had a postoperative empirical antibiotherapy with combination of vancomycine and piperacillin-tazobactam or vancomycine and cefepime

Exclusion Criteria:

  • none

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): NCT03850860


Contacts
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Contact: Eugenie Mabrut, CRA 0426732938 eugenie.mabrut@chu-lyon.fr
Contact: Florent Valour, Md,PhD (00-33)0426732938 florent.valour@chu-lyon.fr

Locations
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France
Hospices Civils de Lyon Recruiting
Lyon, France, 69004
Contact: Eugenie Mabrut, CRA         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Study Director: Florent Valour, Md,PhD HCL

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Responsible Party: Eugénie MABRUT, clinical research assistant, Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03850860     History of Changes
Other Study ID Numbers: 18-326
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Eugénie MABRUT, Hospices Civils de Lyon:
prosthetic joint infection
empirical antibiotherapy

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases
Vancomycin
Anti-Bacterial Agents
Tazobactam
Piperacillin
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action