TuberculosisFrenchTBNCT06893757
Prospective Cohort of People Starting Treatment for Tuberculosis Disease in France (FrenchTB)
An observational study of Tuberculosis, run by ANRS, Emerging Infectious Diseases at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- How many people
- 2,000 participants
- Where
- 2 sitesFrance
- Study dates
- 6 May 2026to Jun 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All persons included in the cohort will be followed up as part of routine care.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Not yet recruiting
AP-HP Hôpital Saint Louis - Service des Maladies Infectieuses et Tropicales
Paris, 75010
Nathalie DE CASTRO, Dr, +33 (0)1 42 49 45 72, nathalie.de-castro@aphp.fr
- Recruiting
Service de pneumologie et maladies infectieuses, Centre hospitalier Delafontaine
Saint-Denis
Yacine Tandjaoui-Lambiotte Tandjaoui-Lambiotte, Dr
About this study
Official title: 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.
Read the 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
- Keywords
- infectious diseases, tuberculosis, clinical, social sciences, public health, Comorbidities, epidemiology, Treatment and care, Transmission, France, biobank, mycobacterial collection, cohort, prospective
- Medical subject headings
- Tuberculosis, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention | People starting treatment for tuberculosis disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: through treatment completion; Month 12
Secondary outcomes (27)
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.
Measured: Month 2
Positive culture
Number of Positive culture after 5 months of treatment
Measured: Month 5
Tuberculosis-related death
Number of deaths directly related to tuberculosis in the year following diagnosis
Measured: 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
Measured: 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
Measured: Month 12
Transfer or loss to follow-up
Number of transfers or loss of follow-up
Measured: Month 5
All-cause mortality
Occurrence and causes of death after tuberculosis diagnosis after inclusion and causes
Measured: Until Month 24
Tuberculosis relapse
Recurrence of positive culture of respiratory samples after the end of treatment and after cultures become negative during treatment
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Measured: Baseline, Month 12, completion or failure treatment
Functional impact and repercussions of respiratory sequelae
Functional evaluation measured by the 6-minute walk test
Measured: 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
Measured: Completion treatment (up to 12 months), Month 24
Functional impact and repercussions of respiratory sequelae
Pulse oximetry
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 2, Month 2, completion of treatment
Health literacy
Questionnaire
Measured: Baseline, Day 3, Day 7
Screening for precariousness
PRECAR score
Measured: Baseline, Day 3, Day 7, Month 2, Month 12
Complementary support for medical follow-up to compliance with treatment
Questionnaire
Measured: 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.
Measured: Baseline, Month 2, completion or failure of treatment (up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start6 May 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- University of Bordeaux, Amiens University Hospital, Centre National de la Recherche Scientifique, France, Saint Antoine University Hospital, University of Lyon, Claude Bernard University, University Hospital, Bordeaux, Saint-Louis Hospital, Paris, France, Centre Hospitalier Universitaire, Amiens, Hôpital Jean Verdier, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Nathalie DE CASTRO, MD PHD, Principal investigator, Hôpital Saint Louis Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893757
- Sponsor's protocol ID
- ANRS 0464s FrenchTB
- Other IDs
- 2024-A01834-43
- Acronym
- FrenchTB
- Status last verified
- Jun 2026
- First submitted
- 7 Mar 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort of People Starting Treatment for Tuberculosis Disease in France - ANRS 464s FrenchTB
- ClinicalTrials.gov ID
- NCT06893757
- Acronym / sponsor ID
- FrenchTB / ANRS 0464s FrenchTB
- Conditions
- Tuberculosis
- Keywords
- infectious diseases, tuberculosis, clinical, social sciences, public health, Comorbidities, epidemiology, Treatment and care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- University of Bordeaux, Amiens University Hospital, Centre National de la Recherche Scientifique, France, Saint Antoine University Hospital, University of Lyon, Claude Bernard University, University Hospital, Bordeaux, Saint-Louis Hospital, Paris, France, Centre Hospitalier Universitaire, Amiens, Hôpital Jean Verdier, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 6 May 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No Intervention | – | –People starting treatment for tuberculosis disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All persons included in the cohort will be followed up as part of routine care.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
Success of the anti-tuberculosis treatment
Time frame: through treatment completion; Month 12
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.
27 secondary outcomes
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
Functional impact and repercussions of respiratory sequelae
Time frame: Completion treatment, Month 24
Functional impact and repercussions of respiratory sequelae
Time frame: Completion treatment (up to 12 months), Month 24
Functional impact and repercussions of respiratory sequelae
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
Time frame: Baseline, Month 2, completion or failure of treatment, Month 24
Functional impact and repercussions of respiratory sequelae
Time frame: Baseline, Month 2, completion or failure of treatment (up to 12 months)
Quality of life and mental health
Time frame: Baseline, During anti-tuberculosis treatment up to Month 12
Quality of life and mental health
Time frame: Baseline, Month 2, completion or failure of treatment (up to 12 months)
Quality of life and mental health
Time frame: Baseline, Day 3, Day 7
Quality of life and mental health
Time frame: Completion of treatment (up to 12 months)
Quality of life and mental health
Time frame: Baseline to Month 24
Adherence to tuberculosis treatment
Time frame: Week 2, Month 2, completion of treatment
Health literacy
Time frame: Baseline, Day 3, Day 7
Screening for precariousness
Time frame: Baseline, Day 3, Day 7, Month 2, Month 12
Complementary support for medical follow-up to compliance with treatment
Time frame: Month 2, completion of treatment, Month 12
Only in case of TB meningitis
Time frame: Baseline, Month 2, completion or failure of treatment (up to 12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathalie DE CASTRO, MD PHD principal investigator
Hôpital Saint Louis Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by ANRS, Emerging Infectious Diseases at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier MARCY, MD PHD (+33 5 57 57 17 67, olivier.marcy@u-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.