Improving the Diagnostic of Tuberculosis

Not Applicable

Completed

• Conditions: Tuberculosis
• Interventions: Biological: Pharyngeal swab

• Registration Number: NCT02861768
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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The presence of M. tuberculosis in non-invasive throat swabs of patients withdrawn for suspected tuberculosis.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

Not available

Study Timeline

• Study Start: 2013-03-22
• Status Verified: 2016-08
• Study First Submitted: 2016-08-05
• Study First Submitted QC: 2016-08-09
• Study First Posted: 2016-08-10
• Primary Completion: 2019-02-08
• Study Completion: 2019-02-08
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 991

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
diagnosis of M.tuberculosis infection	Pharyngeal swab	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients with microbiological diagnosis of M. tuberculosis infection	3 years

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France