- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04236349
Tuberculosis Cohort in the North of Paris
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mechai Frédéric, MD
- Phone Number: 336 26 69 31 78
- Email: frederic.mechai@aphp.fr
Study Locations
-
-
Seine Saint Denis
-
Bobigny, Seine Saint Denis, France, 93000
- Recruiting
- Avicenne
-
Contact:
- Mechai Frédéric, MD
- Phone Number: 33626693178
- Email: frederic.mechai@aphp.fr
-
Contact:
- Yazdanpanah Yazdan, MD
- Email: yazdan.yazdanpanah@aphp.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion criteria :
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
CO1TB: observational
patients with pulmonary and extrapulmonary tuberculosis
|
|
CO2TB: immunogenetics
patient with pulmonary and extrapulmonary tuberculosis and meet the following criteria:
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of known treatment outcomes
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of inclusions by center
Time Frame: 1 year
|
1 year
|
|
Number of opposition to study participation among eligible patients
Time Frame: 1 year
|
1 year
|
|
Number of lost to follow-up
Time Frame: 1 year
|
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)
|
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
|
secondary outcome for CO2TB patients.
rare variants with strong effect will be identified with Whole Exome sequencing method
|
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)
|
secondary outcome for CO2TB patients
|
Day 0, week 2, month 2; at the end of treatment (month 6 or month 9 or month 12 depend on treatment duration)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016FM961
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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