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

ANRS, Emerging Infectious Diseases2,000 enrolled

Overview

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.

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 Type

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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.

Time frame: through treatment completion; Month 12

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.

Time frame: through treatment completion; Month 12

Secondary Outcomes

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.

Time frame: Month 2

Positive culture

Number of Positive culture after 5 months of treatment

Time frame: Month 5

Tuberculosis-related death

Number of deaths directly related to tuberculosis in the year following diagnosis

Time frame: Month 5

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

Time frame: Month 5

Ongoing treatment at Month 12 due to interruption, resistance, adverse events, or initial failure

Number of treatment ongoing at 12 months because interrupted for more than two months or modified for resistance, side effects/intolerance, initial failure

Time frame: Month 12

Transfer or loss to follow-up

Number of transfers or loss of follow-up

Time frame: Month 5

All-cause mortality

Occurrence and causes of death after tuberculosis diagnosis after inclusion and causes

Time frame: Until Month 24

Tuberculosis relapse

Recurrence of positive culture of respiratory samples after the end of treatment and after cultures become negative during treatment

Time frame: Between end of treatment and Month 24

Clinical and radiological post-tuberculosis respiratory sequelae and not related to another pulmonary pathology

Rate of persistent respiratory symptoms such as coughing, dyspnoea, chest pain and/or wheezing

Time frame: treatment completion until Month 24

Clinical and radiological post-tuberculosis respiratory sequelae and not related to another pulmonary pathology and/or hypoxaemia

Oxygen saturation 88% or lower and PaO2 lower 60 mmHg in ambient air at a distance from an acute episode

Time frame: treatment completion until Month 24

Clinical and radiological post-tuberculosis respiratory sequelae and not related to another Pulmonary pathology

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).

Time frame: Baseline, completion or failure treatment (up to 12 months)