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Improving the Diagnostic of Tuberculosis

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ClinicalTrials.gov Identifier: NCT02861768
Recruitment Status : Unknown
Verified August 2016 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : August 10, 2016
Last Update Posted : August 10, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Study Description
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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The presence of M. tuberculosis in non-invasive throat swabs of patients withdrawn for suspected tuberculosis.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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 2013
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: diagnosis of M.tuberculosis infection Biological: Pharyngeal swab


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients with microbiological diagnosis of M. tuberculosis infection [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. pulmonary tuberculosis diagnostic time. [ Time Frame: 3years ]
  2. Prevalence of diagnosed patients Beijing [ Time Frame: 3 years ]
  3. Direct cost of microbiological diagnosis of extra Beijing genotype [ Time Frame: 3 years ]
    (compared to the cost of the kit TB), reported the percentage of patients diagnosed Beijing.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861768


Contacts
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Contact: MICHEL DRANCOURT michel.drancourt@ap-hm.fr
Contact: alexandra GIULIANI alexandra.giuliani@ap-hm.fr

Locations
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France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France
Contact: MICHEL DRANCOURT       michel.drancourt@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: catherine GEINDRE Assistance Publique Hopitaux De Marseille
More Information
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02861768    
Other Study ID Numbers: 2012-49
2012-A01598-35 ( Registry Identifier: ansm )
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
 Bacterial Infections
Bacterial Infections and Mycoses
Infections