Bacterial Epidemiology and Empirical Antibiotherapy in Patients With Prosthetic Joint Infection

NCT03191292 | Completed

• 1 other identifier: 69HCL17_0306
• Study Type: observational
• Target: 567
• Locations: 1 country
• Sites: 1

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.

Conditions

Joint Infection

Keywords

probabilistic antibiotherapy; prosthetic joint infection; treatment failure

Outcome Measures

Primary Outcomes (2)

• identification of bacteria involved in patients with prosthetic joint infection

  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 \[\< 1 year vs. \> 1 year\])

  3 weeks after the surgery

• collection of probabilistic antibiotic treatment in patients with prosthetic joint infection

  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.

  the day of surgery

Secondary Outcomes (2)

• adverse events

  up to 24 months after antibiotic therapy disruption

• Treatment failure

  up to 24 months after antibiotic therapy disruption

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient with prosthetic joint infection and treated with probabilistic antibiotherapy after a first surgery

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital de la Croix Rousse

Lyon, 69004, France

Location

Related Links

• Related Info

Study Officials

• Tristan Ferry, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: June 19, 2017
• Study Start: June 1, 2016
• Primary Completion: April 30, 2017
• Study Completion: April 30, 2017
• Last Updated: August 24, 2017

Record last verified: 2017-08

Locations

FR (1)