NCT02817711

Lyon BJI Cohort Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2002-07-01
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2016-06-29
• Last updated: 2017-01-04

Locations

1 site across 1 country: France