Improving the Diagnostic of Tuberculosis

April 20, 2023 updated by: Assistance Publique Hopitaux De Marseille

The presence of M. tuberculosis in non-invasive throat swabs of patients withdrawn for suspected tuberculosis.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. Measure the time to diagnosis of pulmonary TB by comparing the sample versus noninvasive pharyngeal samples taken routinely.
  2. Evaluation of the direct cost of the diagnosis of M. tuberculosis by comparing the sample versus noninvasive pharyngeal samples taken routinely.
  3. Beijing genotype prevalence among patients with pulmonary tuberculosis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

991

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • France
      • Marseille, France
        • Assistance Publique Hopitaux de Marseille

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient taken for microbiological examinations "kit mycobacterium"
  • Patient Major (> 18 years).
  • Patient who freely signed the informed written consent.
  • Patient affiliated to a system of social security. Exclusion criteria
  • 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.

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: diagnosis of M.tuberculosis infection
Biological: Pharyngeal swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with microbiological diagnosis of M. tuberculosis infection
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pulmonary tuberculosis diagnostic time.
Time Frame: 3years
3years
Prevalence of diagnosed patients Beijing
Time Frame: 3 years
3 years
Direct cost of microbiological diagnosis of extra Beijing genotype
Time Frame: 3 years
(compared to the cost of the kit TB), reported the percentage of patients diagnosed Beijing.
3 years

Collaborators and Investigators

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

Sponsor

Assistance Publique Hopitaux De Marseille

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

March 22, 2013

Primary Completion (Actual)

February 8, 2019

Study Completion (Actual)

February 8, 2019

Study Registration Dates

First Submitted

August 5, 2016

First Submitted That Met QC Criteria

August 9, 2016

First Posted (Estimate)

August 10, 2016

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 20, 2023

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-49
  • 2012-A01598-35 (Registry Identifier: ansm)

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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