Pulmonary TuberculosisNCT04236349
Tuberculosis Cohort in the North of Paris
An observational study of Pulmonary Tuberculosis and Extra Pulmonary Tuberculosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Tuberculosis (TB) is the leading cause of death from infectious disease in the world, just behind HIV / AIDS. Since 2005, the department of Seine Saint Denis, the poorest of France with difficult socio-economic conditions, has the highest incidence rate in metropolitan France, higher than that of Paris. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Tuberculosis, Extra Pulmonary Tuberculosis
- What is being tested?
- immunogenetics
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2018to 17 Feb 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with pulmonary or extrapulmonary tuberculosis
Who may be able to join
- Patient newly admitted to a consultation or hospitalization at a participating facility
- Patient with pulmonary or extrapulmonary tuberculosis confirmed on a suggestive bacteriology (direct examination, GeneXpert MTB / RIF PCR and / or culture positive) or evocative histology (evocative aspect with gigantocellular epithelioid granuloma with or without caseous necrosis) or suspicion of tuberculosis not confirmed with introduction of anti-tuberculosis treatment
Who cannot join
- Refusal to give one's non-opposition to participate in the study
- Patient on antituberculous treatment for more than 21 days at the inclusion visit
- Patient already participating in another research protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tuberculosis Cohort in the North of Paris: Pilot Phase
Tuberculosis (TB) is the leading cause of death from infectious disease in the world, just behind HIV / AIDS. Since 2005, the department of Seine Saint Denis, the poorest of France with difficult socio-economic conditions, has the highest incidence rate in metropolitan France, higher than that of Paris. In 2012, the rate of reporting was 10 times higher among people born abroad compared to those born in France, with the highest rates found among people born in sub-Saharan Africa and Asia.
It is proposed to establish for the first time in France a cohort of patients with TB disease to better understand the characteristics of patients with adverse treatment outcomes and propose solutions to achieve better control of TB. This study would recruit 200 patients per year for 5 years associated with 5 years of follow-up for a total duration of the study which would be 10 years. Given the economic stakes induced by such a study, a pilot feasibility study will be carried out initially. This smaller cohort over a shorter inclusion and follow-up period will make it possible to assess the feasibility of the large-scale cohort (princeps cohort) and to propose possible improvements to the protocol or questionnaire if problems arise in the future after achievement of this pilot study.
Read the detailed description
There are flagrant shortcomings in the health care pathways of patients with TB, with a significant proportion of unknown treatment outcomes, including a large number of those lost to follow-up secondary transmission, tuberculosis recurrence, and emergence from tuberculosis. resistances. Unknown treatment outcomes are treatment outcomes not reported at 12 months of treatment initiation (lost to follow-up, transfer, no information). Health actors must mobilize to better understand the characteristics of patients with incomplete treatment outcomes and to provide solutions for better control of tuberculosis in our region. This study also want to evaluate the relationship between plasma concentrations of major antituberculosis drugs (rifampicin and isoniazid) and treatment outcomes. This study propose to constitute for the first time in France a cohort of patients presenting a TB disease in order to meet these objectives.The original study would recruit 200 patients per year for 5 years associated with 5 years of follow-up for a total duration of the study estimated at 10 years. Given the economic stakes involved in such a study, a pilot feasibility study is carry out, which is the subject of this research protocol. This smaller cohort over a shorter inclusion and follow-up period will make it possible to evaluate the feasibility of the large-scale cohort, to propose possible improvements of the protocol if problems are raised at the end of the study and launch the cohort at the same time if the study is considered feasible. A cohort should be as representative as possible of the population and the pathology studied. Thus, the population to be studied here corresponds to any adult patient or child with TB disease confirmed, consulting or hospitalized in one of the six participating services, and initiating treatment in the center. As part of the pilot study, a 1-year follow-up will be conducted to assess the feasibility of the original study. This duration is appropriate and sufficient for a first evaluation of the distribution of treatment outcomes at 1 year follow-up in the context of a study, in accordance with World Health Organisation (WHO) recommendations. Nevertheless, this one-year follow-up will only partially capture the risk of tuberculosis relapses, as part of the pilot study. This, however, will indirectly reflect the quality of the patient management system and thus assess the feasibility of the original study. It is an observational study of prospective multicentric cohort type, initially piloting, then intended to be extended by a larger original study, if it is considered feasible.
- Being tested
- immunogenetics
- Keywords
- Tuberculosis, cohort, lost of follow up
- Medical subject headings
- Tuberculosis, Pulmonary, Tuberculosis, Extrapulmonary, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunogeneticsGenetic
blood samples at day 0, week 2, month 2; at the end of treatment (month 6 or month 9 or month 12 depend on treatment duration)
| Study group | Role | What they receive |
|---|---|---|
| CO1TB: observational | patients with pulmonary and extrapulmonary tuberculosis | |
| CO2TB: immunogenetics | patient with pulmonary and extrapulmonary tuberculosis and meet the following criteria:
* informed consent form signed by the patient or by the representative of parental authority
* affiliation to social security (beneficiary or assignee)
* HIV negative Receives: Genetic: immunogenetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of known treatment outcomes
Measured: 1 year
Secondary outcomes (6)
number of inclusions by center
Measured: 1 year
Number of opposition to study participation among eligible patients
Measured: 1 year
Number of lost to follow-up
Measured: 1 year
Number of variables filled in for each consultation or follow-up call
Measured: At: inclusion (Day 0), Week 2 (w2), 1st month (M1), 2nd month (M2), 6th month (M6), 12th month (M12)
Genetics: identification of rare variants with strong effect for the earliest forms of pulmonary tuberculosis (before 25 y.o) and / or belonging to families with several patients and / or with recurrent forms of tuberculosis.
secondary outcome for CO2TB patients. rare variants with strong effect will be identified with Whole Exome sequencing method
Measured: Day 0
immunology: identification of pro or anti inflammatory markers
secondary outcome for CO2TB patients
Measured: Day 0, week 2, month 2; at the end of treatment (month 6 or month 9 or month 12 depend on treatment duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start1 May 2018
- Primary completion17 Feb 2021
- Study completion17 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary TuberculosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 30 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236349
- Sponsor's protocol ID
- 2016FM961
- Status last verified
- Jul 2026
- First submitted
- 10 Jan 2020
- Last updated
- 11 Aug 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 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tuberculosis Cohort in the North of Paris: Pilot Phase
- ClinicalTrials.gov ID
- NCT04236349
- Acronym / sponsor ID
- 2016FM961
- Keywords
- Tuberculosis, cohort, lost of follow up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 17 Feb 2021 (actual)
- Study completion
- 17 Feb 2021 (actual)
- First posted
- 22 Jan 2020 (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.
Tuberculosis (TB) is the leading cause of death from infectious disease in the world, just behind HIV / AIDS. Since 2005, the department of Seine Saint Denis, the poorest of France with difficult socio-economic conditions, has the highest incidence rate in metropolitan France, higher than that of Paris. In 2012, the rate of reporting was 10 times higher among people born abroad compared to those born in France, with the highest rates found among people born in sub-Saharan Africa and Asia.
It is proposed to establish for the first time in France a cohort of patients with TB disease to better understand the characteristics of patients with adverse treatment outcomes and propose solutions to achieve better control of TB. This study would recruit 200 patients per year for 5 years associated with 5 years of follow-up for a total duration of the study which would be 10 years. Given the economic stakes induced by such a study, a pilot feasibility study will be carried out initially. This smaller cohort over a shorter inclusion and follow-up period will make it possible to assess the feasibility of the large-scale cohort (princeps cohort) and to propose possible improvements to the protocol or questionnaire if problems arise in the future after achievement of this pilot study.
Detailed description
There are flagrant shortcomings in the health care pathways of patients with TB, with a significant proportion of unknown treatment outcomes, including a large number of those lost to follow-up secondary transmission, tuberculosis recurrence, and emergence from tuberculosis. resistances. Unknown treatment outcomes are treatment outcomes not reported at 12 months of treatment initiation (lost to follow-up, transfer, no information). Health actors must mobilize to better understand the characteristics of patients with incomplete treatment outcomes and to provide solutions for better control of tuberculosis in our region. This study also want to evaluate the relationship between plasma concentrations of major antituberculosis drugs (rifampicin and isoniazid) and treatment outcomes. This study propose to constitute for the first time in France a cohort of patients presenting a TB disease in order to meet these objectives.The original study would recruit 200 patients per year for 5 years associated with 5 years of follow-up for a total duration of the study estimated at 10 years. Given the economic stakes involved in such a study, a pilot feasibility study is carry out, which is the subject of this research protocol. This smaller cohort over a shorter inclusion and follow-up period will make it possible to evaluate the feasibility of the large-scale cohort, to propose possible improvements of the protocol if problems are raised at the end of the study and launch the cohort at the same time if the study is considered feasible. A cohort should be as representative as possible of the population and the pathology studied. Thus, the population to be studied here corresponds to any adult patient or child with TB disease confirmed, consulting or hospitalized in one of the six participating services, and initiating treatment in the center. As part of the pilot study, a 1-year follow-up will be conducted to assess the feasibility of the original study. This duration is appropriate and sufficient for a first evaluation of the distribution of treatment outcomes at 1 year follow-up in the context of a study, in accordance with World Health Organisation (WHO) recommendations. Nevertheless, this one-year follow-up will only partially capture the risk of tuberculosis relapses, as part of the pilot study. This, however, will indirectly reflect the quality of the patient management system and thus assess the feasibility of the original study. It is an observational study of prospective multicentric cohort type, initially piloting, then intended to be extended by a larger original study, if it is considered feasible.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CO1TB: observational | – | –patients with pulmonary and extrapulmonary tuberculosis |
| CO2TB: immunogenetics | – | Genetic: immunogeneticspatient with pulmonary and extrapulmonary tuberculosis and meet the following criteria: * informed consent form signed by the patient or by the representative of parental authority * affiliation to social security (beneficiary or assignee) * HIV negative |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with pulmonary or extrapulmonary tuberculosis
Key inclusion criteria (2 listed)
- Patient newly admitted to a consultation or hospitalization at a participating facility
- Patient with pulmonary or extrapulmonary tuberculosis confirmed on a suggestive bacteriology (direct examination, GeneXpert MTB / RIF PCR and / or culture positive) or evocative histology (evocative aspect with gigantocellular epithelioid granuloma with or without caseous necrosis) or suspicion of tuberculosis not confirmed with introduction of anti-tuberculosis treatment
Key exclusion criteria (3 listed)
- Refusal to give one's non-opposition to participate in the study
- Patient on antituberculous treatment for more than 21 days at the inclusion visit
- Patient already participating in another research protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunogeneticsblood samples at day 0, week 2, month 2; at the end of treatment (month 6 or month 9 or month 12 depend on treatment duration) | Genetic | CO2TB: immunogenetics |
Primary outcome
Number of known treatment outcomes
Time frame: 1 year
6 secondary outcomes
number of inclusions by center
Time frame: 1 year
Number of opposition to study participation among eligible patients
Time frame: 1 year
Number of lost to follow-up
Time frame: 1 year
Number of variables filled in for each consultation or follow-up call
Time frame: At: inclusion (Day 0), Week 2 (w2), 1st month (M1), 2nd month (M2), 6th month (M6), 12th month (M12)
Genetics: identification of rare variants with strong effect for the earliest forms of pulmonary tuberculosis (before 25 y.o) and / or belonging to families with several patients and / or with recurrent forms of tuberculosis.
Time frame: Day 0
immunology: identification of pro or anti inflammatory markers
Time frame: Day 0, week 2, month 2; at the end of treatment (month 6 or month 9 or month 12 depend on treatment duration)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Tuberculosis and Extra Pulmonary Tuberculosis, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of known treatment outcomes (time frame: 1 year). 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 11 Aug 2026.