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Lyon BJI Cohort Study

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ClinicalTrials.gov Identifier: NCT02817711
Recruitment Status : Recruiting
First Posted : June 29, 2016
Last Update Posted : January 4, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

The prospective Cohort includes all patients with bone or joint infection (BJI), with or without implant. The aim of this Cohort is to improve the knowledges about the treatment failure and the occurrence of serious adverse events. Various data of patients included are collected and will be analysed.

Patients with a bone or joint infection are treated at the department of infectious diseases, at Infectious disease department of Hospices Civils de Lyon. They have regularly a consultation with a physician: 2-3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery and 24 months after surgery. It allows to the physician to follow the evolution of the patient under treatment and after discontinuation of the treatment.

Several data are collected during the follow-up concerning: demographics data, treatment including the use of off-label antibiotics for the treatment of BJI, adverse events, microbiology, surgeries, healing or relapse, date of symptoms, ASA score, implant or not. If there is an implant, the date of implantation and the number of the prosthesis infected are collected.

This cohort allows to improve knowledge concerning the treatment failure and the occurrence of adverse events.


Condition or disease
Bone and Joint Infection

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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Lyon BJI Cohort Study
Study Start Date : July 2002
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022



Primary Outcome Measures :
  1. Treatment Failure in patients with bone or joint infection [ Time Frame: 2 years ]
    Up to 30% of patients experience a relapse, even when the treatment is considered as optimal. This Cohort will improve knowledges about the mechanisms of treatment failure by collecting data concerning infectious disease, surgery and microbiology and by analysing the cases where treatment failed. Treatment failure is defined by local clinical and/or microbiological relapse, under treatment or after treatment discontinuation.


Secondary Outcome Measures :
  1. Occurrence of serious adverse events in patients with bone or joint infection [ Time Frame: 6 months ]
    The duration of the antibiotic treatment is long : several weeks, several months or even several years in some cases. Patients are then exposed to adverse events. The data concerning theses adverse events are collected in this Cohort : molecule, dosage, description of the adverse event, a change in treatment. A severity grade is allocated to every adverse event, based on the " Common Terminology Criteria for Adverse Events ". This is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term (from 1 to 5). Severe adverse events have a grade >=3.



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study includes all patients who have a bone and joint infection, with or without implant, and treated in the department of infectious disease at the HCL.
Criteria

Inclusion Criteria:

  • patients with bone or joint infection, with or without implant

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): NCT02817711


Contacts
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Contact: Eugénie Mabrut, ARC (0)426732938 ext +33 eugenie.mabrut@chu-lyon.fr
Contact: Tristan Ferry, MD, PhD (0)472071107 ext +33 tristan.ferry@chu-lyon.fr

Locations
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France
Centre de reference des infections ostéo-articulaires, Hôpital de la Croix-Rousse, 103 Grande Rue de la Croix-Rousse Recruiting
Lyon, France, 69004
Contact: Eugénie Mabrut, ARC    (0)426732938 ext +33    eugenie.mabrut@chu-lyon.fr   
Contact: Tristan Ferry, MD, PHD    (0)472071107 ext +33    tristan.ferry@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Tristan Ferry, MD, PhD Centre de reference des infections ostéo-articulaires
Additional Information:
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02817711    
Other Study ID Numbers: 69HCL16_0388
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017
Keywords provided by Hospices Civils de Lyon:
infection
bone and joint infection
relapse
adverse event
Additional relevant MeSH terms:
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Infection