Bone Resistant Tuberculosis

Completed

• Conditions: Bone and Osteoarticular Infection Due to MDR M. Tuberculosis Strains

• Registration Number: NCT04928378
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The recommendations for the treatment of MDR tuberculosis are based on pulmonary tuberculosis since there is a lack of specific recommendations for TB bone and osteoarticular disease, including those due to multi drug resistance strains (MDR IOATB). Given the lack of data regarding MDR IOATB, it may be helpful to study the diagnosis, medical treatment, surgical indications and prognosis of a cohort of MDR IOATB patients.

Detailed Description

Due to the lack, in the guidelines regarding bone and osteoarticular infections due to MDR M. tuberculosis strains, this study aims to characterize the diagnosis, management and outcome of patients with osteoarticular infection due to MDR M. tuberculosis in France (MDR IOATB).

Aim: descriptive study of diagnosis, therapeutics and outcome of patients with bone and osteoarticular infection with MDR IOATB in France.

Set up: patients registered in the database of the National Reference Center (CNR) for MDR IOATB in France, treated for MDR IOATB between January 1, 2007 and December 31, 2018 will be included and analyzed.

Study design: retrospective study on historical cohort

Study Timeline

• Study Start: 2021-05-17
• Study First Submitted: 2021-05-21
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-16
• Primary Completion: 2021-07-01
• Status Verified: 2022-01
• Study Completion: 2022-01-21
• Last Update Submitted: 2022-05-09
• Last Update Posted: 2022-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Any patient with an MDR IOATB whose sample and / or strain has been referred to the National Reference Center (CNR) for mycobacteria in France, will be included.

Exclusion Criteria

• Patient refusing to have their data used.
• Patients under guardianship or curators, patients under legal protection will not be included.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
study of infected population with MDR TB IOATB	Through study completion, an average of 1 year	Description of patients with MDR IOATB on anamnestic, clinical, paraclinical, diagnosis, prognosis, therapeutic and outcome level.; Data collected for : demographics (age, sex), history of previous treatment for tuberculosis (list of), immunocompromised status (and which kind), clinical presentation, tuberculosis localization, administered treatment (sort, duration), adverse events (number of patients with treatment-related adverse events using WHO scale), surgery (y or n and which surgery: descriptive) and treatment outcomes death, cure, relapse, lost in follow up)

Secondary Outcome Measures

Name	Time	Method
Drug susceptibility testing	Through study completion, an average of 1 year	Testing for phenotypic drug susceptibility using the proportion method and genetic mutations involved in antituberculosis drug resistance identified with biomolecular tool.

Trial Locations

Locations (1)

Pitié Salpêtrière Hospital; 🇫🇷 Paris, France