Clinical trial NCT06893757: Prospective Cohort of People Starting Treatment for Tuberculosis Disease in France (FrenchTB)
Official title: Prospective Cohort of People Starting Treatment for Tuberculosis Disease in France - ANRS 464s FrenchTB
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Tuberculosis
Keywords: infectious diseases
tuberculosis
clinical
social sciences
public health
Comorbidities
epidemiology
Treatment and care
Transmission
France
biobank
mycobacterial collection
cohort
prospective
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: University of Bordeaux
name: Amiens University Hospital
name: Centre National de la Recherche Scientifique, France
name: Saint Antoine University Hospital
name: University of Lyon
name: Claude Bernard University
name: University Hospital, Bordeaux
name: Saint-Louis Hospital, Paris, France
name: Centre Hospitalier Universitaire, Amiens
name: Hôpital Jean Verdier
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2025-03-25
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All persons included in the cohort will be followed up as part of routine care.

Brief summary: 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.

Detailed description: Main objectif:

To describe the sociodemographic, clinical, radiologic, and bacteriologic characteristics, as well as comorbidities and their impact on treatment outcomes and relapse rate up to 24 months after the start of anti-tuberculosis treatment in people with tuberculosis disease diagnosed in France.

Secondary objectives:

* Evaluate the effects of immunosuppression (HIV infection, organ transplantation, immunosuppressive treatments) on tuberculosis symptomatology, complications (including immune reconstitution inflammatory syndromes (IRIS), and drug interactions), treatment response and survival.
* Describe the characteristics of severe (meningeal, pericardial, miliary, etc.) or complicated forms of tuberculosis, including resistant tuberculosis, their management (treatment of resistant TB, use of anti-TNF, corticoids), their impact on treatment outcomes, relapse rates up to 24 months, sequelae and survival.
* Describe representations of the disease and its care, its impact on quality of life, and the effect of social determinants, situations of precariousness, health literacy, belonging to key populations (incarcerated, migrant and/or homeless people) as well as mental health disorders and addictions on compliance, experience of the disease, follow-up, and treatment outcomes.
* Describe the effect of new short-course tuberculosis treatments on adherence, disease experience, follow-up and treatment outcomes.
* Describe post-tuberculosis pulmonary sequelae, study their association with immunosuppression, pharmacological dosages, other comorbidities, tobacco and alcohol consumption, and measure physiological, structural and functional disorders, their impact on quality of life and survival.
* Study the potential diagnostic and prognostic value of new biomarkers in people with tuberculosis and the effect of exposure to anti-tuberculosis treatment on response to tuberculosis therapy.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: the success of the anti-tuberculosis treatment
timeFrame: through treatment completion; Month 12
measure: Success of the anti-tuberculosis treatment
timeFrame: through treatment completion; Month 12
Secondary outcomes:
measure: Early microbiological response
timeFrame: Month 2
measure: Treatment failure
timeFrame: Month 5
measure: Treatment failure
timeFrame: Month 5
measure: Treatment failure
timeFrame: Month 5
measure: Treatment failure
timeFrame: Month 12
measure: Treatment failure
timeFrame: Month 5
measure: Deaths
timeFrame: Until Month 24
measure: Relapses of tuberculosis
timeFrame: through treatment completion until Month 24
measure: Relapses of tuberculosis
timeFrame: through treatment completion until Month 24
measure: Clinical and radiological post-tuberculosis respiratory sequelae and not related to another pulmonary pathology
timeFrame: treatment completion until Month 24
measure: Clinical and radiological post-tuberculosis respiratory sequelae and not related to another pulmonary pathology and/or hypoxaemia
timeFrame: treatment completion until Month 24
measure: Clinical and radiological post-tuberculosis respiratory sequelae and not related to another Pulmonary pathology
timeFrame: Baseline, completion or failure treatment (up to 12 months)
measure: Functional impact and repercussions of respiratory sequelae
timeFrame: Baseline, Month 12, completion or failure treatment
measure: Functional impact and repercussions of respiratory sequelae
timeFrame: Completion treatment, Month 24
measure: Functional impact and repercussions of respiratory sequelae
timeFrame: Completion treatment (up to 12 months), Month 24
measure: Functional impact and repercussions of respiratory sequelae
timeFrame: Baseline, week 2, Month 12, completion or failure of treatment (up to 12 months), Month 24
measure: Functional impact and repercussions of respiratory sequelae
timeFrame: Baseline, Month 2, completion or failure of treatment, Month 24
measure: Functional impact and repercussions of respiratory sequelae
timeFrame: Baseline, Month 2, completion or failure of treatment (up to 12 months)
measure: Functional impact and repercussions of respiratory sequelae
timeFrame: Baseline, Month 2, completion or failure of treatment (up to 12 months)
measure: Quality of life and mental health
timeFrame: Baseline, Month 2, completion or failure of treatment (up to 12 months)
measure: Quality of life and mental health
timeFrame: Baseline, Month 2, completion or failure of treatment (up to 12 months)
measure: Quality of life and mental health
timeFrame: Baseline, Month 2, completion or failure of treatment (up to 12 months)
measure: Quality of life and mental health
timeFrame: Baseline, Month 2, completion or failure of treatment (up to 12 months)
measure: Quality of life and mental health
timeFrame: Baseline, Day 3, Day 7
measure: Quality of life and mental health
timeFrame: Baseline, Day 3, Day 7
measure: Quality of life and mental health
timeFrame: Completion of treatment (up to 12 months)
measure: Quality of life and mental health
timeFrame: Baseline, Day 3, Day 7, Month 12, completion or failure of treatment, Month 24
measure: Quality of life and mental health
timeFrame: Baseline, Day 3, Day 7, Month 12, completion or failure of treatment, Month 24
measure: Adherence to tuberculosis treatment
timeFrame: Week 2, Month 2, completion of treatment
measure: Health literacy
timeFrame: Baseline, Day 3, Day 7
measure: Screening for precariousness
timeFrame: Baseline, Day 3, Day 7, Month 2, Month 12
measure: Complementary support for medical follow-up to compliance with treatment
timeFrame: Month 2, completion of treatment, Month 12
measure: Only in case of TB meningitis
timeFrame: Baseline, Month 2, completion or failure of treatment (up to 12 months)
Other outcomes:
Locations:
Study officials:
affiliation: Hôpital Saint Louis Paris
name: Nathalie DE CASTRO, MD PHD
role: PRINCIPAL_INVESTIGATOR
References: