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

NCT ID: NCT06893757

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2031-06-30

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.

Conditions

Tuberculosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

No Intervention

People starting treatment for tuberculosis disease

No interventions assigned to this group

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bordeaux

OTHER

Sponsor Role: collaborator

Amiens University Hospital

OTHER

Sponsor Role: collaborator

Centre National de la Recherche Scientifique, France

OTHER

Sponsor Role: collaborator

Saint Antoine University Hospital

OTHER

Sponsor Role: collaborator

University of Lyon

OTHER

Sponsor Role: collaborator

Claude Bernard University

OTHER

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: collaborator

Saint-Louis Hospital, Paris, France

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: collaborator

Hôpital Jean Verdier

OTHER

Sponsor Role: collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathalie DE CASTRO, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Saint Louis Paris

Central Contacts

Olivier MARCY, MD PHD

Role: CONTACT

olivier.marcy@u-bordeaux.fr

+33 5 57 57 17 67

Other Identifiers

2024-A01834-43

Identifier Type: OTHER

Identifier Source: secondary_id

ANRS 0464s FrenchTB

Identifier Type: -

Identifier Source: org_study_id