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Bone Resistant Tuberculosis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04928378
Acronym
TboneR
Enrollment
23
Registered
2021-06-16
Start date
2021-05-17
Completion date
2022-01-21
Last updated
2022-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone and Osteoarticular Infection Due to MDR M. Tuberculosis Strains

Keywords

Mycobacterium tuberculosis, Multi drug resistance, Bone, osteoarticular

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

Interventions

OTHERDescriptive retrospective study

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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
study of infected population with MDR TB IOATBThrough study completion, an average of 1 yearDescription 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

MeasureTime frameDescription
Drug susceptibility testingThrough study completion, an average of 1 yearTesting for phenotypic drug susceptibility using the proportion method and genetic mutations involved in antituberculosis drug resistance identified with biomolecular tool.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026