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Clinical Trials/NCT03191292
NCT03191292
Completed
Not Applicable

Bacterial Epidemiology and Empirical Antibiotherapy in Patients With Prosthetic Joint Infection

Hospices Civils de Lyon1 site in 1 country567 target enrollmentJune 1, 2016
ConditionsJoint Infection

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Joint Infection
Sponsor
Hospices Civils de Lyon
Enrollment
567
Locations
1
Primary Endpoint
collection of probabilistic antibiotic treatment in patients with prosthetic joint infection
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The purpose of this study is to establish a bacterial epidemiology in patients who present a prosthetic joint infection and for which a surgery is necessary. At the time of the first surgery, as the bacteria responsible for the infection are not known, a probabilistic antibiotherapy is initiated at once after the surgical treatment. The antibiotherapy is then adapted to the bacteria from samples collected during the surgery when they are identified (the delay is 14-21 days).

The study will focus on bacteria identified on samples collected during the surgery; the delay between the implantation of the prosthesis and the presentation of symptoms will be considered : more than one year vs. less than one year.

Investigators assume that there is not the same type of bacteria involved in those two cases of delays and that the probabilistic antibiotherapy may be not optimal when the symptoms are presented more than one year after implantation of the prosthesis. A probabilistic antibiotherapy not adapted lead to develop resistance for the bacteria and decrease the chance to cure the patient (increasing of relapse).

The result of this study will allow medical doctors to have an optimal probabilistic antibiotherapy, depending on the delay between implantation of the prosthesis and the presentation of the symptoms.

Registry
clinicaltrials.gov
Start Date
June 1, 2016
End Date
April 30, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patient with prosthetic joint infection and treated with probabilistic antibiotherapy, between 2010 and 2015, at the Croix-Rousse Hospital

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

collection of probabilistic antibiotic treatment in patients with prosthetic joint infection

Time Frame: the day of surgery

The type of molecule used and dosage will be described. Probabilistic antibiotic treatment is initiated immediately after the surgery, before the bacteria is identified. The samples are put in bacteriological culture media. The time to obtain results is usually 3 weeks maximum after the surgery because this is the delay for slow-growing bacteria to grow. Then, the empirical treatment can be amended in order to have an antibiotic treatment adapted to the bacteria found.

identification of bacteria involved in patients with prosthetic joint infection

Time Frame: 3 weeks after the surgery

The samples collected during the surgery are put in bacteriological culture media. Bacteriological culture of samples collected during surgery for all patients included is made allowing to identify which type of bacteria is involved in the infection, depending on the chronology of the infection (delay between implantation and the presentation of the symptoms \[\< 1 year vs. \> 1 year\])

Secondary Outcomes

  • Treatment failure(up to 24 months after antibiotic therapy disruption)
  • adverse events(up to 24 months after antibiotic therapy disruption)

Study Sites (1)

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