Improving the Diagnostic of Tuberculosis

NCT ID: NCT02861768

Last Updated: 2023-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

991 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-22

Study Completion Date

2019-02-08

Brief Summary

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The presence of M. tuberculosis in non-invasive throat swabs of patients withdrawn for suspected tuberculosis.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.

Detailed Description

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Conditions

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Tuberculosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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diagnosis of M.tuberculosis infection

Group Type EXPERIMENTAL

Pharyngeal swab

Intervention Type BIOLOGICAL

Interventions

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Pharyngeal swab

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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catherine GEINDRE

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

Locations

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Assistance Publique Hopitaux de Marseille

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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2012-A01598-35

Identifier Type: REGISTRY

Identifier Source: secondary_id

2012-49

Identifier Type: -

Identifier Source: org_study_id

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