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

Prospective Cohort of People Starting Treatment for Tuberculosis Disease in France - ANRS 464s FrenchTB

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.

Study Overview

• Status: Recruiting
• Conditions: Tuberculosis

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 Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Olivier MARCY, MD PHD; Phone Number: +33 5 57 57 17 67; Email: olivier.marcy@u-bordeaux.fr

Study Locations

• France
  • Paris, France, 75010
    • Not yet recruiting
    • AP-HP Hôpital Saint Louis - Service des Maladies Infectieuses et Tropicales
    • Contact: Nathalie DE CASTRO, Dr; Phone Number: +33 (0)1 42 49 45 72; Email: nathalie.de-castro@aphp.fr
  • Saint-Denis, France
    • Recruiting
    • Service de pneumologie et maladies infectieuses, Centre hospitalier Delafontaine
    • Contact: Yacine Tandjaoui-Lambiotte Tandjaoui-Lambiotte, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
No Intervention; People starting treatment for tuberculosis disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	through treatment completion; Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Month 2
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	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	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).	Baseline, completion or failure treatment (up to 12 months)
Functional impact and repercussions of respiratory sequelae	Functional evaluation measured by the 6-minute walk test	Completion treatment, Month 24
Functional impact and repercussions of respiratory sequelae	Spirometry - FEV1/FVC ratio of greater than 0.70 and both FEV1 and FVC above 80% of the predicted value	Completion treatment (up to 12 months), Month 24
Functional impact and repercussions of respiratory sequelae	Pulse oximetry	Baseline, week 2, Month 12, completion or failure of treatment (up to 12 months), Month 24
Functional impact and repercussions of respiratory sequelae	Imaging (scanner)	Baseline, Month 2, completion or failure of treatment, Month 24
Quality of life and mental health	Stigma scale - Responses to each item are measured on a five-point scale (ranging from zero 'strongly disagree' to four 'strongly agree'). Higher scores indicate higher levels of depression stigma.	Completion of treatment (up to 12 months)
Adherence to tuberculosis 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.	Week 2, Month 2, completion of treatment
Health literacy	Questionnaire	Baseline, Day 3, Day 7
Screening for precariousness	PRECAR score	Baseline, Day 3, Day 7, Month 2, Month 12
Complementary support for medical follow-up to compliance with treatment	Questionnaire	Month 2, completion of treatment, Month 12
Only in case of TB meningitis	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.	Baseline, Month 2, completion or failure of treatment (up to 12 months)
Positive culture	Number of Positive culture after 5 months of treatment	Month 5
Tuberculosis-related death	Number of deaths directly related to tuberculosis in the year following diagnosis	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	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	Month 12
Transfer or loss to follow-up	Number of transfers or loss of follow-up	Month 5
All-cause mortality	Occurrence and causes of death after tuberculosis diagnosis after inclusion and causes	Until Month 24
Tuberculosis relapse	Recurrence of positive culture of respiratory samples after the end of treatment and after cultures become negative during treatment	Between end of treatment and Month 24
Functional impact and repercussions of respiratory sequelae	The 3 components of the St Georges's Respiratory Questionnaire (SGRQ): symptoms (frequency and severity), activity (effects on and adjustment of everyday activities), and psychosocial impact. The total score has a maximum of 100 points, with values ranging from 0 to 100.	Baseline, Month 12, completion or failure treatment
Functional impact and repercussions of respiratory sequelae	Chest X-ray2.Other imaging for extrapulmonary involvement	Baseline, Month 2, completion or failure of treatment (up to 12 months)
Quality of life and mental health	Psycho-trauma screening (PC-PTSD-5) - 20-item questionnaire, corresponding to the DSM-5 symptom criteria for PTSD. The self-report rating scale is 0-4 for each symptom, reflecting a change from 1-5 in the DSM-IV version.	Baseline, During anti-tuberculosis treatment up to Month 12
Quality of life and mental health	Anxiety questionnaire (GAD-7) - Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety. EQ-5D-5L - The UI is calculated from patient scoring of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). For each dimension, participants are asked to mark between 1: 'no problems' to 5: 'unable to/extreme problems'. Depression (PHQ-9) -Total scores of 5, 10, 15 and 20 represent the thresholds for mild, moderate, moderately severe and severe depression, respectively. Note: Question 9 is a single screening question on suicide risk.	Baseline, Month 2, completion or failure of treatment (up to 12 months)
Quality of life and mental health	Psycho-trauma screening (PC-PTSD-5) - 20-item questionnaire, corresponding to the DSM-5; .symptom criteria for PTSD. The self-report rating scale is 0-4 for each symptom, reflecting a change from 1-5 in the DSM-IV version.Hunger scale (HHS) - rating scale from 0 to 10, where 0 is painful hunger and 10 is painful fullness.	Baseline, Day 3, Day 7
Quality of life and mental health	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. Tobacco questionnaire (Fagerström) - Test for Nicotine Dependence, the three yes/no items are scored 0 (no) and 1 (yes). The three multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10.	Baseline to Month 24

Collaborators and Investigators

• Sponsor: ANRS, Emerging Infectious Diseases
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; University of Bordeaux; Centre Hospitalier Universitaire, Amiens; University Hospital, Bordeaux; Saint-Louis Hospital, Paris, France; Saint Antoine University Hospital; Claude Bernard University; Amiens University Hospital; University of Lyon; Centre National de la Recherche Scientifique, France; Hôpital Jean Verdier
• Investigators: Principal Investigator: Nathalie DE CASTRO, MD PHD, Hôpital Saint Louis Paris

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2031

Study Registration Dates

• First Submitted: March 7, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: epidemiology; biobank; France; tuberculosis; cohort; prospective; public health; clinical; Transmission; infectious diseases; Comorbidities; social sciences; Treatment and care; mycobacterial collection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Actinomycetales Infections; Mycobacterium Infections; Pathological Conditions, Signs and Symptoms; Communicable Diseases; Tuberculosis
• Other Study ID Numbers: ANRS 0464s FrenchTB; 2024-A01834-43 (Other Identifier: ID RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No