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

NCT06893757 | Not Yet Recruiting

• 2 other identifiers: ANRS 0464s FrenchTB2024-A01834-43
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tuberculosis

Keywords

infectious diseases; tuberculosis; clinical; social sciences; public health; Comorbidities; epidemiology; Treatment and care; Transmission; France; biobank; mycobacterial collection; cohort; prospective

Outcome Measures

Primary Outcomes (2)

• the success of the anti-tuberculosis treatment

  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.

  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.

  through treatment completion; Month 12

Secondary Outcomes (33)

• Early microbiological response

  Month 2

• Treatment failure

  Month 5

• Treatment failure

  Month 5

• Treatment failure

  Month 5

• Treatment failure

  Month 12

Study Arms (1)

No Intervention

People starting treatment for tuberculosis disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All persons included in the cohort will be followed up as part of routine care.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• University of Bordeaux: collaborator
• Amiens University Hospital: collaborator
• Centre National de la Recherche Scientifique, France: collaborator
• Saint Antoine University Hospital: collaborator
• University of Lyon: collaborator
• Claude Bernard University: collaborator
• University Hospital, Bordeaux: collaborator
• Saint-Louis Hospital, Paris, France: collaborator
• Centre Hospitalier Universitaire, Amiens: collaborator
• Hôpital Jean Verdier: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

* Blood samples for the storage of whole blood, plasma, PBMCs * Urine samples * Exhaled breath condensate or exhaled breath (in a subgroup of participants) * Samples of other fluids or tissues depending on the investigations (body fluids, biological fluids, biopsy tissue) carried out as part of routine care and for which a sample is available (no additional sample) * Sputum

MeSH Terms

Conditions

Tuberculosis; Communicable Diseases

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nathalie DE CASTRO, MD PHD

  Hôpital Saint Louis Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier MARCY, MD PHD

CONTACT

+33 5 57 57 17 67; olivier.marcy@u-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 25, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2031
• Last Updated: March 25, 2025

Record last verified: 2025-03