Lyon BJI Cohort Study

NCT02817711 | Unknown

• 1 other identifier: 69HCL16_0388
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone and Joint Infection

Keywords

infection; bone and joint infection; relapse; adverse event

Outcome Measures

Primary Outcomes (1)

• Treatment Failure in patients with bone or joint infection

  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.

  2 years

Secondary Outcomes (1)

• Occurrence of serious adverse events in patients with bone or joint infection

  6 months

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Centre de reference des infections ostéo-articulaires, Hôpital de la Croix-Rousse, 103 Grande Rue de la Croix-Rousse

Lyon, 69004, France

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Infections; Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tristan Ferry, MD, PhD

  Centre de reference des infections ostéo-articulaires

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eugénie Mabrut, ARC

CONTACT

(0)426732938; eugenie.mabrut@chu-lyon.fr

Tristan Ferry, MD, PhD

CONTACT

(0)472071107; tristan.ferry@chu-lyon.fr

Study Design

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

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: June 29, 2016
• Study Start: July 1, 2002
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: January 4, 2017

Record last verified: 2017-01

Locations

FR (1)