Bacterial Epidemiology and Empirical Antibiotherapy in Patients With Prosthetic Joint Infection

Joint Infection Clinical Trial

Official title:

Bacterial Epidemiology and Empirical Antibiotherapy in Patients With Prosthetic Joint Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03191292
• Other study ID #: 69HCL17_0306
• Status: Completed
• Phase: N/A
• First received: April 21, 2017
• Last updated: August 23, 2017
• Start date: June 1, 2016
• Est. completion date: April 30, 2017

Study information

• Verified date: August 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 567
• Est. completion date: April 30, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Arthritis, Infectious
• Communicable Diseases
• Infection
• Joint Infection

Locations

Country	Name	City	State
France	Hôpital de la Croix Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	adverse events	This secondary outcome will focus on severe adverse events induced by this probabilistic antibiotherapy.	up to 24 months after antibiotic therapy disruption
Secondary	Treatment failure	Treatment failure is defined by local clinical and/or microbiological relapse; and/or need for additional surgery; death of septic origin	up to 24 months after antibiotic therapy disruption

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