Improving the Diagnostic of Tuberculosis

Tuberculosis Clinical Trial

Official title:

Improving the Diagnostic of Tuberculosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02861768
• Other study ID #: 2012-49
• Secondary ID: 2012-A01598-35
• Status: Completed
• Phase: N/A
• Start date: March 22, 2013
• Est. completion date: February 8, 2019

Study information

• Verified date: August 2016
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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The presence of M. tuberculosis in non-invasive throat swabs of patients withdrawn for suspected tuberculosis.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 991
• Est. completion date: February 8, 2019
• Est. primary completion date: February 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Biological:
• Pharyngeal swab

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with microbiological diagnosis of M. tuberculosis infection		3 years
Secondary	pulmonary tuberculosis diagnostic time.		3years
Secondary	Prevalence of diagnosed patients Beijing		3 years
Secondary	Direct cost of microbiological diagnosis of extra Beijing genotype	(compared to the cost of the kit TB), reported the percentage of patients diagnosed Beijing.	3 years