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OpenTrials
Completed

NCT Number: NCT02861768

Improving the Diagnostic of Tuberculosis

The presence of M. tuberculosis in non-invasive throat swabs of patients withdrawn for suspected tuberculosis.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

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pharyngeal swab

Biological

Primary outcomes

  1. Percentage of patients with microbiological diagnosis of M. tuberculosis infection

    Time frame: 3 years

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Aug 10, 2016
Registry last updated
Apr 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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