An observational study in Tuberculosis, sponsored by ANRS, Emerging Infectious Diseases. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by ANRS, Emerging Infectious Diseases · Observational
Among 12 studies in Tuberculosis by ANRS, Emerging Infectious Diseases — 2 open to participants now, 2 under way, none of them phase 3. Tuberculosis · ANRS, Emerging Infectious Diseases.
Among the 12 studies in Tuberculosis by ANRS, Emerging Infectious Diseases, this one is the only one that started in 2026, is one of 4 observational ones, and was the 12th registered.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 253 across 317 observational studies indexed under Tuberculosis.
Browse Tuberculosis studies →2 of the 12 studies in Tuberculosis by ANRS, Emerging Infectious Diseases are open now, in 2 countries. Each count lists the studies.
Of the 109 Tuberculosis studies recruiting now, 64 (59%) set no upper age limit and 35 (32%) stop at 75 or younger; 48 take children under 18; 30 take healthy volunteers.
This study: 18 Years and older · all sexes.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 1 started in 2026.
Median enrollment 460 across the 7 interventional studies, 300 across the 5 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
ANRS, Emerging Infectious Diseases is the lead sponsor of 215 studies on the registry; 38 are open to participants now.
1 of the studies in Tuberculosis by ANRS, Emerging Infectious Diseases that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06893757ANRS, Emerging Infectious DiseasesProspective Cohort of People Starting Treatment for Tuberculosis Disease in France (FrenchTB) | 2027-06 |
Among the 12 studies in Tuberculosis by ANRS, Emerging Infectious Diseases, from their registry updates:
Nothing recorded among them since 2026-09-25.
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:
All persons included in the cohort will be followed up as part of routine care.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
People starting treatment for tuberculosis disease
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
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)
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.
Time frame: Baseline, Month 12, completion or failure treatment
Functional impact and repercussions of respiratory sequelae
Functional evaluation measured by the 6-minute walk test
Time frame: 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
Time frame: Completion treatment (up to 12 months), Month 24
Functional impact and repercussions of respiratory sequelae
Pulse oximetry
Time frame: 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)
Time frame: Baseline, Month 2, completion or failure of treatment, Month 24
Functional impact and repercussions of respiratory sequelae
Chest X-ray2.Other imaging for extrapulmonary involvement
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Day 3, Day 7
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.
Time frame: Completion of treatment (up to 12 months)
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.
Time frame: Baseline to Month 24
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.
Time frame: Week 2, Month 2, completion of treatment
Health literacy
Questionnaire
Time frame: Baseline, Day 3, Day 7
Screening for precariousness
PRECAR score
Time frame: Baseline, Day 3, Day 7, Month 2, Month 12
Complementary support for medical follow-up to compliance with treatment
Questionnaire
Time frame: 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.
Time frame: Baseline, Month 2, completion or failure of treatment (up to 12 months)
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