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Tuberculosis Cohort in the North of Paris

NCT04236349 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2020-01-22

No results posted yet for this study

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. 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.

Conditions

  • Pulmonary Tuberculosis
  • Extra Pulmonary Tuberculosis

Interventions

GENETIC

immunogenetics

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)

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2020-01-31
Completion
2021-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04236349 on ClinicalTrials.gov