Improving the Diagnostic of Tuberculosis

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Completed

Conditions: Tuberculosis

Treatments: Biological: Pharyngeal swab

Study type: Interventional

Funder types: Other

Identifiers

NCT02861768

2012-49

2012-A01598-35 (Registry Identifier)

Details and patient eligibility

About

The presence of M. tuberculosis in non-invasive throat swabs of patients withdrawn for suspected tuberculosis.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

Enrollment: 991 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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991 participants in 1 patient group

diagnosis of M.tuberculosis infection

Experimental group

Treatment:

Biological: Pharyngeal swab