Tuberculosis Cohort Avicenne Hospital

NCT05539014 | Recruiting

• 1 other identifier: APHP220889
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Tuberculosis, Pulmonary

Outcome Measures

Primary Outcomes (1)

• Proportion of patients followed for tuberculosis with unfavourable treatment outcome at month12.

  Proportion of patients followed for tuberculosis with unfavourable treatment outcome at month12.

  inclusions for 4 years with 1 year follow-up

Secondary Outcomes (3)

• 1) Proportion for each unfavourable treatment outcome at M12 (death, treatment not completed at 12 months, treatment stopped and not resumed, lost to follow-up, transferred to another establishment and lack of information concerning the patient).

  inclusions for 4 years with 1 year follow-up

• Risk factors (patient characteristics and other determinants) for unfavourable tuberculosis treatment outcomes at 12 months.

  inclusions for 4 years with 1 year follow-up

• Socio-economic, clinical, bacteriological

  inclusions for 4 years with 1 year follow-up

Interventions

Data collection OTHER

Prospectif data collection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The inclusion criteria are TB out- or in-patient newly treated in one of the inclusion centers for pulmonary or extra-pulmonary TB 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. The non-inclusion criteria were: opposition to participate in the study, anti-tuberculosis treatment for more than 7 days at the inclusion visit and participation in another research protocol.

You may qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Hopital Avicenne

Bobigny, 93000, France

RECRUITING

Hôpital Avicenne

Bobigny, 93009, France

NOT YET RECRUITING

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 14, 2022
• Study Start: January 18, 2023
• Primary Completion (Estimated): October 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)