Completed

NCT Number: NCT04928378

Bone Resistant Tuberculosis

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.

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Key information

Conditions

Bone and Osteoarticular Infection Due to MDR M. Tuberculosis Strains

Sex eligibility

All sexes

Study type

Observational

Primary location

Pitié Salpêtrière Hospital

Paris, 75013, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Descriptive retrospective study

Other

characterization of the diagnosis, management and outcome of patients with osteoarticular infection due to MDR M. tuberculosis in France (MDR IOATB).

Primary outcomes

study of infected population with MDR TB IOATB

Time frame: 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 outcomes

Drug susceptibility testing

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: TboneR

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2022
First posted: Jun 16, 2021
Registry last updated: May 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.