Tuberculosis Cohort Avicenne Hospital
ConditionTuberculosis, Pulmonary
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
opposition to participate in the study, anti-tuberculosis treatment for more than 7 days at the inclusion visit and participation in another research protocol.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Data collection
Other interventionProspectif data collection
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
inclusions for 4 years with 1 year follow-upSecondary outcomes
1
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).
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).
Time frame
inclusions for 4 years with 1 year follow-up2
Risk factors (patient characteristics and other determinants) for unfavourable tuberculosis treatment outcomes at 12 months.
Risk factors (patient characteristics and other determinants) for unfavourable tuberculosis treatment outcomes at 12 months.
Time frame
inclusions for 4 years with 1 year follow-up3
Socio-economic, clinical, bacteriological
Socio-economic, clinical, bacteriological
Time frame
inclusions for 4 years with 1 year follow-upSponsors and contacts
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Source ClinicalTrials.gov