Improving the Diagnostic of Tuberculosis

• Sponsor: Assistance Publique Hopitaux De Marseille (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02861768
• Collaborator: (none)
• Enrollment: 36,000
• Location: 1
• Arm: 1
• Duration (Months): 79
• Patients Per Site Per Month: 455.6

Study Details

Study Description

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The presence of M. tuberculosis in non-invasive throat swabs of patients withdrawn for suspected tuberculosis.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

Condition or Disease	Intervention/Treatment	Phase
Tuberculosis	Biological: Pharyngeal swab	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 36000 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Improving the Diagnostic of Tuberculosis
• Study Start Date: Mar 1, 2013
• Anticipated Primary Completion Date: Mar 1, 2019
• Anticipated Study Completion Date: Oct 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of patients with microbiological diagnosis of M. tuberculosis infection [3 years]

Secondary Outcome Measures

1. pulmonary tuberculosis diagnostic time. [3years]

2. Prevalence of diagnosed patients Beijing [3 years]

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique Hopitaux de Marseille	Marseille		France

Sponsors and Collaborators

• Assistance Publique Hopitaux De Marseille

Investigators

• Study Director: catherine GEINDRE, Assistance Publique Hopitaux De Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique Hopitaux De Marseille
• ClinicalTrials.gov Identifier: NCT02861768
• Other Study ID Numbers: 2012-49; 2012-A01598-35
• First Posted: Aug 10, 2016
• Last Update Posted: Aug 10, 2016
• Last Verified: Aug 1, 2016

• Additional relevant MeSH terms: Tuberculosis

Study Results

No Results Posted as of Aug 10, 2016