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Comparison Between Two Strategies for the Diagnosis of TB

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ClinicalTrials.gov Identifier: NCT02961569
Recruitment Status : Completed
First Posted : November 11, 2016
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Célia Lloret-Linares, MD PhD, Hopital Lariboisière

Brief Summary:
Tuberculosis (TB) is a major cause of death among the "communicable" diseases in the world. Pulmonary TB, the main localization, leads to the dissemination of cases. An earlier diagnosis of contagious pulmonary TB is a cornerstone to stop the air transmission. The aim of the study will be to compare two strategies, in patients with a chest-X-ray in favour of contagious pulmonary TB: the classical strategy of sputa collection during three consecutive early mornings, versus the studied strategy of sputa collection at hour h, hour h+1, hour h+2 during the first early morning.

Condition or disease Intervention/treatment Phase
Pulmonary TB Procedure: sputum collection for acid fast bacilli Not Applicable

Detailed Description:
Tuberculosis (TB) is a major cause of death among the "communicable" diseases in the world. Pulmonary TB, the main localization, leads to the dissemination of cases. An earlier diagnosis of contagious pulmonary TB is a cornerstone to stop the air transmission by starting earlier treatment. The aim of the study will be to compare two strategies, in patients with a chest-X-ray in favour of pulmonary TB: the classical strategy of sputa collection during three consecutive early mornings, versus the studied strategy of sputa collection at hour h, hour h+1, hour h+2 during the first early morning.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparative Study Between the Classical Strategy and a Faster, Daily Collection for the Diagnosis of Contagious Pulmonary Tuberculosis
Actual Study Start Date : July 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
One open-label arm
Patients suspected of pulmonary TB will have sputum collection for acid fast bacilli by the classical strategy (Day 1, Day 2 and Day 3) and the intervention sputum collection for acid fast bacilli by the same day strategy (Hour 1, 2 and 3)
Procedure: sputum collection for acid fast bacilli
spontaneous or post fiberoptic bronchoscopy sputa




Primary Outcome Measures :
  1. Comparison between the sensitivities of the two strategies for detection of Acid fast bacilli (AFB) on direct stain [ Time Frame: one year ]
    Ziehl Neelsen



Information from the National Library of Medicine

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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:

  • All adult patients suspected of pulmonary TB (symptoms: lost weight, hemoptysis, chronic cough or fever, or a Chest-X-Ray (CXR) evocative of pulmonary TB)

Exclusion Criteria:

  • Patients who refused or were unable to give written consent

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): NCT02961569


Locations
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France
Hôpital Lariboisière
Paris, Ile-de-France, France, 75010
Sponsors and Collaborators
Hopital Lariboisière
Investigators
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Principal Investigator: Célia Lloret-Linares, MD, PhD Unité de Recherches Thérapeutiques, Hôpital Lariboisière

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Responsible Party: Célia Lloret-Linares, MD PhD, Principal Investigator, Hopital Lariboisière
ClinicalTrials.gov Identifier: NCT02961569     History of Changes
Other Study ID Numbers: TBsputum
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Tuberculosis, Pulmonary
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections