TboneR: Bone Resistant Tuberculosis

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT04928378

Collaborator

(none)

Enrollment

Location

8.2

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bone and Osteoarticular Infection Due to MDR M. Tuberculosis Strains	Other: Descriptive retrospective study

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 Design

Study Type:

Observational

Actual Enrollment :

23 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Management of Osteoarticular Infection Due to Multidrug Resistant Mycobacterium Tuberculosis Strains in France

Actual Study Start Date :

May 17, 2021

Actual Primary Completion Date :

Jul 1, 2021

Actual Study Completion Date :

Jan 21, 2022

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.