Prospective Cohort of People Starting Treatment for Tuberculosis Disease in France (FrenchTB)

ConditionTuberculosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorANRS, Emerging Infectious Diseases

About this trial

The French Tuberculosis Cohort is a prospective, national, multicenter, low-intervention study including subjects aged 18 years and older with tuberculosis disease for which inpatient treatment is initiated. The goal of this observational study is to follow-up and anti-tuberculosis treatment will be provided according to current French recommendations. Participants will provide sociodemographic, clinical, biological, radiological and bacteriological data at various protocol visits at 2 days, 1 and 2 weeks, 2 months, at the end of treatment, 12 and 24 months. Consenting participants will have samples collected at scheduled visits for the establishment of a biobank. This will include blood, urine, breath and hair samples. The positive mycobacterial strains will constitute a specimen bank.

Eligibility criteria

Qualifiers

Aged ≥18 years.

Diagnosis of tuberculosis by microbiological or clinical means, including on the basis of a pathological examination for extrapulmonary tuberculosis leading to a Compulsory Declaration (CD) and treated for less than 8 days.

Have signed a voluntary, informed and written consent (at the latest on the day of inclusion and before any examination carried out as part of the research), or alternatively, consent from relatives in cases of tuberculous meningitis or other serious forms of tuberculosis with impaired consciousness or confusion, until the person is able to give their consent.

Disqualifiers

Presence of significant cognitive impairment that, in the opinion of the site investigator or designated person, may affect the ability to give reliable informed consent (except in the specific case of meningeal tuberculosis).

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

2,000 Participants
are grouped into 1 trial group

Sponsors and collaborators

ANRS, Emerging Infectious Diseases

Lead sponsor

University of Bordeaux

Collaborator

Amiens University Hospital

Collaborator

Centre National de la Recherche Scientifique, France

Collaborator

Saint Antoine University Hospital

Collaborator

University of Lyon

Collaborator

Claude Bernard University

Collaborator

University Hospital, Bordeaux

Collaborator

Saint-Louis Hospital, Paris, France

Collaborator

Centre Hospitalier Universitaire, Amiens

Collaborator

Hôpital Jean Verdier

Collaborator

Institut National de la Santé Et de la Recherche Médicale, France

Collaborator