NCT02861768

Brief Summary

The presence of M. tuberculosis in non-invasive throat swabs of patients withdrawn for suspected tuberculosis. Hypothesis 10% of patients infected by M. tuberculosis are carrier of M. tuberculosis pharyngeal. Secondary

  1. 1.Measure the time to diagnosis of pulmonary TB by comparing the sample versus noninvasive pharyngeal samples taken routinely.
  2. 2.Evaluation of the direct cost of the diagnosis of M. tuberculosis by comparing the sample versus noninvasive pharyngeal samples taken routinely.
  3. 3.Beijing genotype prevalence among patients with pulmonary tuberculosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
991

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 22, 2013

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2019

Completed
Last Updated

April 21, 2023

Status Verified

August 1, 2016

Enrollment Period

5.9 years

First QC Date

August 5, 2016

Last Update Submit

April 20, 2023

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with microbiological diagnosis of M. tuberculosis infection

    3 years

Secondary Outcomes (3)

  • pulmonary tuberculosis diagnostic time.

    3years

  • Prevalence of diagnosed patients Beijing

    3 years

  • Direct cost of microbiological diagnosis of extra Beijing genotype

    3 years

Study Arms (1)

diagnosis of M.tuberculosis infection

EXPERIMENTAL
Biological: Pharyngeal swab

Interventions

Pharyngeal swabBIOLOGICAL
diagnosis of M.tuberculosis infection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient taken for microbiological examinations "kit mycobacterium"
  • Patient Major (\> 18 years).
  • Patient who freely signed the informed written consent.

You may not qualify if:

  • Patient minor (\<18 years).
  • Patient pregnant or nursing.
  • Major Patient under guardianship.
  • Private Patient liberty or under court order.
  • Patient refusing to sign the informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, France

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • catherine GEINDRE

    Assistance Publique Hopitaux De Marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2016

First Posted

August 10, 2016

Study Start

March 22, 2013

Primary Completion

February 8, 2019

Study Completion

February 8, 2019

Last Updated

April 21, 2023

Record last verified: 2016-08

Locations

FR(1)