NCT04236349

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

1.8 years

First QC Date

January 10, 2020

Last Update Submit

January 17, 2020

Conditions

Pulmonary TuberculosisExtra Pulmonary Tuberculosis

Keywords

Tuberculosis, cohort, lost of follow up

Outcome Measures

Primary Outcomes (1)

  • Number of known treatment outcomes

    1 year

Secondary Outcomes (6)

  • number of inclusions by center

    1 year

  • Number of opposition to study participation among eligible patients

    1 year

  • Number of lost to follow-up

    1 year

  • Number of variables filled in for each consultation or follow-up call

    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.

    Day 0

  • +1 more secondary outcomes

Study Arms (2)

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

Genetic: immunogenetics

Interventions

immunogeneticsGENETIC

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)

CO2TB: immunogenetics

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient with pulmonary or extrapulmonary tuberculosis

You may qualify if:

  • 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

You may not qualify if:

  • Refusal to give one's non-opposition to participate in the study
  • Patient already participating in another research protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avicenne

Bobigny, Seine Saint Denis, 93000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

biological collection (DNA library; RNA library; plasma library; cell library)

MeSH Terms

Conditions

Tuberculosis, PulmonaryTuberculosis, ExtrapulmonaryTuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Mechai Frédéric, MD

CONTACT

336 26 69 31 78frederic.mechai@aphp.fr

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

January 10, 2020

First Posted

January 22, 2020

Study Start

May 1, 2018

Primary Completion

January 31, 2020

Study Completion

January 31, 2021

Last Updated

January 22, 2020

Record last verified: 2020-01

Locations

FR(1)