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Clinical Trials in France / NCT05539014
Recruiting Observational

Tuberculosis Cohort Avicenne Hospital

NCT05539014 · tracked via the Priya Life Science France tracker
Sponsor
Assistance Publique - Hôpitaux de Paris
Phase
Observational
Started
2023-01-18
Last updated
2023-11-18

Condition(s) studied

Tuberculosis, Pulmonary

Investigational drug(s) / intervention(s)

Data collection

Data collection: Prospectif data collection

Study summary

Tuberculosis represents the second highest death rate from an infectious disease in the world, just after COVID-19. The most affected department of France is Seine-Saint-Denis. Since 2005, this department with difficult socio-economic conditions has the highest incidence rate in metropolitan France, higher than that of Paris. In 2012, the reporting rate 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 constitute for the first time in France a cohort of patients with tuberculosis disease to better understand the characteristics of patients with unfavorable treatment outcomes and ultimately, to propose solutions to obtain better control of tuberculosis. This study would recruit all patients with tuberculosis disease for at least 4 years associated with 1 year of follow-up for a total duration of the study of at least 5 years.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Tuberculosis out- or in-patient newly treated in one of the inclusion centers for pulmonary or extra-pulmonary * Tu confirmed bacteriologically (direct examination, Gen-eXpert MTB/RIF and/or positive culture), suggestive histology (epithelioid gigantocellular granuloma with or without caseous necrosis), or strong clinical suspicion of tuberculosis, even if not yet biologically confirmed but with * A decision to introduce treatment. Exclusion Criteria: * opposition to participate in the study, anti-tuberculosis treatment for more than 7 days at the inclusion visit and participation in another research protocol.

Primary outcome measure(s)

  • Proportion of patients followed for tuberculosis with unfavourable treatment outcome at month12. — inclusions for 4 years with 1 year follow-up
    Proportion of patients followed for tuberculosis with unfavourable treatment outcome at month12.

Trial sites (2)

FacilityCityRegionStatus
Hopital Avicenne Bobigny France Recruiting
Hôpital Avicenne Bobigny France Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05539014 on ClinicalTrials.gov ↗ ← All trials in France