ANRS 0464s - French TB Cohort

Prospective cohort of individuals starting treatment for active tuberculosis in France

Last updated on 20 May 2026

Main points

  • The French TB cohort is a prospective, observational, national, multicentre, low-intervention study involving subjects aged 18 years and older with tuberculosis – a disease for which treatment is initiated during hospitalisation.
  • Follow-up and anti-tuberculosis treatment will be carried out in accordance with current recommendations in France. Participants will provide sociodemographic, clinical, biological, radiological and bacteriological data at various visits scheduled in the protocol at 3 days, 1 and 2 weeks, 2 months, at the end of treatment, and at 12 and 24 months.
  • For participants who consent, samples for the creation of a biobank will be taken during the scheduled visits. These will include blood, urine, respiratory, hair and fluid/tissue samples taken as part of the diagnosis.

Type of study

National, prospective, multicentre cohort, classified as minimal risk and minimal constraint interventional research (RIPH 2).

More information on the French TB cohort

Objectives

Main objective

Describe the sociodemographic, clinical, radiological and bacteriological characteristics, as well as comorbidities, in people diagnosed with tuberculosis in France and assess their impact on treatment outcomes and relapse rates up to 24 months after the start of antituberculosis treatment.

Secondary objectives

  1. Assess the effects of immunosuppression (HIV infection, immunosuppressive treatments) on the symptoms of tuberculosis, its complications, including paradoxical reactions and immune reconstitution inflammatory syndromes (IRIS), as well as treatment response and survival.
  2. Describe the severity of tuberculosis and the characteristics of severe forms (meningeal, pericardial, miliary, etc.) or complicated forms (resistant tuberculosis, adverse effects, etc.), their management (treatment of resistant TB, use of anti-TNF agents, corticosteroids), their impact on treatment outcomes, relapse rates up to 24 months, sequelae and survival.
  3. Describe the effect of social determinants, precarious situations, health literacy, belonging to key populations (migrants and/or homeless people), as well as mental health disorders and addictions on adherence, quality of life, care and follow-up, and tuberculosis treatment outcomes.
  4. Describe the effect of new tuberculosis treatment strategies (particularly short courses of treatment) on treatment adherence, quality of life, follow-up, and treatment outcomes.
  5. Describe post-tuberculosis pulmonary sequelae (PTLD), study their association with immunosuppression, pharmacological dosages, other comorbidities, including respiratory comorbidities, tobacco and alcohol consumption, and initial severity (particularly radiological), and their impact on quality of life and survival.
  6. To study the potential prognostic value of new biomarkers in people with tuberculosis and the effect of exposure to anti-tuberculosis treatment on the response to tuberculosis treatment.

Principal investigators
Nathalie DE CASTRO – Hôpital Saint Louis, Paris
Claire ANDREJAK – CHU Amiens-Picardie, Amiens

Pathology
Tuberculosis

Promotion
Inserm – ANRS MIE

Starting date
6 May 2026

Number of participants
2,000

Teams
– Methodological coordination: Olivier MARCY – INSERM UMR 1219, IRD EMR 271, Bordeaux
– Infectious Diseases and Respiratory Medicine: Florence ADER – INSERM International Centre for Research in Infectious Diseases 1111, Claude Bernard University, Lyon
– Internal Medicine: Fabrice BONNET – Bordeaux University Hospital, Bordeaux
– Immunology/Biomarkers: Anne BOURGARIT – Jean Verdier Hospital, Paris; Olivier NEYROLLES, Christel VEROLLET, Jérôme NIGOU – CNRS, Toulouse
– Microbiology: Nicolas VEZIRIS – Saint-Antoine Hospital, Paris; Oana DUMITRESCU/Claude Bernard University, Lyon
– Social Sciences and Social Epidemiology: Nicolas VIGNIER / Miriam CASTALDO