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

Not yet recruiting

• Conditions: Tuberculosis

• Registration Number: NCT06893757
• Lead Sponsor: ANRS, Emerging Infectious Diseases

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-07
• Study First Submitted QC: 2025-03-18
• Last Update Submitted: 2025-03-18
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Study Start: 2025-06
• Primary Completion: 2027-06
• Study Completion: 2031-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2000

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the success of the anti-tuberculosis treatment	through treatment completion; 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	through treatment completion; Month 12	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.

Secondary Outcome Measures

Name	Time	Method
Relapses of tuberculosis	through treatment completion until Month 24	Decision by the clinician to resume treatment due to suspected relapse.
Functional impact and repercussions of respiratory sequelae	Baseline, Month 2, completion or failure of treatment (up to 12 months)	Other imaging for extrapulmonary involvement
Early microbiological response	Month 2	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.
Health literacy	Baseline, Day 3, Day 7	Questionnaire
Complementary support for medical follow-up to compliance with treatment	Month 2, completion of treatment, Month 12	Questionnaire
Treatment failure	Month 5	Number of transfers or loss of follow-up
Deaths	Until Month 24	After inclusion and causes
Clinical and radiological post-tuberculosis respiratory sequelae and not related to another pulmonary pathology	treatment completion until Month 24	Rate of persistent respiratory symptoms such as coughing, dyspnoea, chest pain and/or wheezing
Clinical and radiological post-tuberculosis respiratory sequelae and not related to another pulmonary pathology and/or hypoxaemia	treatment completion until Month 24	Oxygen saturation 88% or lower and PaO2 lower 60 mmHg in ambient air at a distance from an acute episode
Clinical and radiological post-tuberculosis respiratory sequelae and not related to another Pulmonary pathology	Baseline, completion or failure treatment (up to 12 months)	and/or impaired lung function as measured by spirometry (FEV1 or FVC \<80% of the theoretical value or FEV1/FVC ratio \<0.70) iv) and/or radiological sequelae defined as the persistence of pulmonary parenchymal abnormalities (nodules, cavities, reticulations, etc.). The anomalies should not be linked to an obvious cause unrelated to tuberculosis (COPD).
Adherence to tuberculosis treatment	Week 2, Month 2, completion of treatment	Psychoactive substances questionnaire (CAGE-AID) - Item responses on the CAGE are scored 0 or 1, with a higher score an indication of alcohol problems. A total score of 2 or greater is considered clinically significant. A score of 2 to 3 indicates a high index of suspicion and a score of 4 is virtually diagnostic for alcoholism.
Quality of life and mental health	Baseline, Day 3, Day 7, Month 12, completion or failure of treatment, Month 24	Alcohol questionnaire (AUDIT-C) - scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety.
Screening for precariousness	Baseline, Day 3, Day 7, Month 2, Month 12	PRECAR score
Only in case of TB meningitis	Baseline, Month 2, completion or failure of treatment (up to 12 months)	Neurocognitive scores - Rankin (MR,) - Measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.; is a 6 point disability scale with possible scores ranging from 0 to 5. A separate category of 6 is usually added for patients who expire.