Tuberculosis Cohort in the North of Paris

January 17, 2020 updated by: Assistance Publique - Hôpitaux de Paris

Tuberculosis Cohort in the North of Paris: Pilot Phase

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.

Study Overview

Status

Unknown

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient with pulmonary or extrapulmonary tuberculosis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CO1TB: observational
patients with pulmonary and extrapulmonary tuberculosis
CO2TB: immunogenetics

patient with pulmonary and extrapulmonary tuberculosis and meet the following criteria:

  • informed consent form signed by the patient or by the representative of parental authority
  • affiliation to social security (beneficiary or assignee)
  • HIV negative
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of known treatment outcomes
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of inclusions by center
Time Frame: 1 year
1 year
Number of opposition to study participation among eligible patients
Time Frame: 1 year
1 year
Number of lost to follow-up
Time Frame: 1 year
1 year
Number of variables filled in for each consultation or follow-up call
Time Frame: At: inclusion (Day 0), Week 2 (w2), 1st month (M1), 2nd month (M2), 6th month (M6), 12th month (M12)
At: inclusion (Day 0), Week 2 (w2), 1st month (M1), 2nd month (M2), 6th month (M6), 12th month (M12)
Genetics: identification of rare variants with strong effect for the earliest forms of pulmonary tuberculosis (before 25 y.o) and / or belonging to families with several patients and / or with recurrent forms of tuberculosis.
Time Frame: Day 0
secondary outcome for CO2TB patients. rare variants with strong effect will be identified with Whole Exome sequencing method
Day 0
immunology: identification of pro or anti inflammatory markers
Time Frame: Day 0, week 2, month 2; at the end of treatment (month 6 or month 9 or month 12 depend on treatment duration)
secondary outcome for CO2TB patients
Day 0, week 2, month 2; at the end of treatment (month 6 or month 9 or month 12 depend on treatment duration)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Anticipated)

January 31, 2020

Study Completion (Anticipated)

January 31, 2021

Study Registration Dates

First Submitted

January 10, 2020

First Submitted That Met QC Criteria

January 17, 2020

First Posted (Actual)

January 22, 2020

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 17, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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