Prospective Cohort of People Starting Treatment for Tuberculosis Disease in France (FrenchTB)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Tuberculosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Cohort of People Starting Treatment for Tuberculosis Disease in France - ANRS 464s FrenchTB
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.
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.
Primary outcome measures
- Proportion of participants with successful anti-tuberculosis treatment outcome, defined as definite or probable cure, by Month 12 [Time frame: through treatment completion; Month 12]
- Success of the anti-tuberculosis treatment [Time frame: through treatment completion; Month 12]
Secondary outcome measures (12)
- Early microbiological response [Time frame: Month 2]
- Positive culture [Time frame: Month 5]
- Tuberculosis-related death [Time frame: Month 5]
- Premature treatment interruption without resumption [Time frame: Month 5]
- Ongoing treatment at Month 12 due to interruption, resistance, adverse events, or initial failure [Time frame: Month 12]
- Transfer or loss to follow-up [Time frame: Month 5]
- All-cause mortality [Time frame: Until Month 24]
- Tuberculosis relapse [Time frame: Between end of treatment and Month 24]
- Clinical and radiological post-tuberculosis respiratory sequelae and not related to another pulmonary pathology [Time frame: treatment completion until Month 24]
- Clinical and radiological post-tuberculosis respiratory sequelae and not related to another pulmonary pathology and/or hypoxaemia [Time frame: treatment completion until Month 24]
- Clinical and radiological post-tuberculosis respiratory sequelae and not related to another Pulmonary pathology [Time frame: Baseline, completion or failure treatment (up to 12 months)]
- Functional impact and repercussions of respiratory sequelae [Time frame: Baseline, Month 12, completion or failure treatment]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
France · 2 centers
- AP-HP Hôpital Saint Louis - Service des Maladies Infectieuses et Tropicales — Paris
- Service de pneumologie et maladies infectieuses, Centre hospitalier Delafontaine — Saint-Denis
Identifiers
NCT: NCT06893757 · ANRS 0464s FrenchTB · 2024-A01834-43