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.
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.
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).
All persons included in the cohort will be followed up as part of routine care.
Cohort
Prospective
Not listed
Proportion of participants with successful anti-tuberculosis treatment outcome, defined as definite or probable cure, by Month 12
Definite cure (microbiological): negative cultures (or direct examination) of respiratory specimens on two occasions during follow-up, in the last month of treatment and on an intermediate specimen, in a participant who has completed treatment and has never met the definition of treatment failure.
Success of the anti-tuberculosis treatment
Probable cure: clinical and radiological improvement of tuberculosis-related symptoms in a participant who has completed treatment and never met the definition of treatment failure.
Early microbiological response
Assessed by the conversion (negativation) of cultures specimens on two occasions during follow-up, in the last month of treatment and on an intermediate specimen, in a participant who has completed treatment and has never met the definition of treatment failure.
Positive culture
Number of Positive culture after 5 months of treatment
Tuberculosis-related death
Number of deaths directly related to tuberculosis in the year following diagnosis
Premature treatment interruption without resumption
Number of interrupted treatments before the end of the planned duration and not resumed (for a reason other than a rejected tuberculosis diagnosis
Click on the lead sponsor to view all of their trials.
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
