Tuberculosis Cohort in the North of Paris
Tuberculosis Cohort in the North of Paris
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.
There are flagrant shortcomings in the health care pathways of patients with TB, with a
 significant proportion of unknown treatment outcomes, including a large number of those lost
 to follow-up secondary transmission, tuberculosis recurrence, and emergence from
 tuberculosis. resistances. Unknown treatment outcomes are treatment outcomes not reported at
 12 months of treatment initiation (lost to follow-up, transfer, no information). Health
 actors must mobilize to better understand the characteristics of patients with incomplete
 treatment outcomes and to provide solutions for better control of tuberculosis in our region.
 This study also want to evaluate the relationship between plasma concentrations of major
 antituberculosis drugs (rifampicin and isoniazid) and treatment outcomes. This study propose
 to constitute for the first time in France a cohort of patients presenting a TB disease in
 order to meet these objectives.The original study would recruit 200 patients per year for 5
 years associated with 5 years of follow-up for a total duration of the study estimated at 10
 years. Given the economic stakes involved in such a study, a pilot feasibility study is carry
 out, which is the subject of this research protocol. This smaller cohort over a shorter
 inclusion and follow-up period will make it possible to evaluate the feasibility of the
 large-scale cohort, to propose possible improvements of the protocol if problems are raised
 at the end of the study and launch the cohort at the same time if the study is considered
 feasible. A cohort should be as representative as possible of the population and the
 pathology studied. Thus, the population to be studied here corresponds to any adult patient
 or child with TB disease confirmed, consulting or hospitalized in one of the six
 participating services, and initiating treatment in the center. As part of the pilot study, a
 1-year follow-up will be conducted to assess the feasibility of the original study. This
 duration is appropriate and sufficient for a first evaluation of the distribution of
 treatment outcomes at 1 year follow-up in the context of a study, in accordance with World
 Health Organisation (WHO) recommendations. Nevertheless, this one-year follow-up will only
 partially capture the risk of tuberculosis relapses, as part of the pilot study. This,
 however, will indirectly reflect the quality of the patient management system and thus assess
 the feasibility of the original study. It is an observational study of prospective
 multicentric cohort type, initially piloting, then intended to be extended by a larger
 original study, if it is considered feasible.
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