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CompletedNCT02961569Updated Apr 28, 2017

Comparison Between Two Strategies for the Diagnosis of TB

An interventional study of sputum collection for acid fast bacilli in Pulmonary TB, sponsored by Hopital Lariboisière. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-28.

Sponsored by Hopital Lariboisière · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jul 2016, registered Oct 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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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Conditions studied

  • Pulmonary TB
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In context

Tuberculosis, Pulmonary

339 studies on the registry are indexed under Tuberculosis, Pulmonary; 69 are open to participants now.

This study's enrollment of 34 is below the median of 152 across 242 interventional studies indexed under Tuberculosis, Pulmonary.

Browse Tuberculosis, Pulmonary studies →

Lead sponsor

Hopital Lariboisière is the lead sponsor of 29 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients who refused or were unable to give written consent
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Other
    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

Interventions

  • Proceduresputum collection for acid fast bacilli

    spontaneous or post fiberoptic bronchoscopy sputa

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What researchers measure

Primary outcomes

  1. Comparison between the sensitivities of the two strategies for detection of Acid fast bacilli (AFB) on direct stain

    Ziehl Neelsen

    Time frame: one year

07

Study locations

1 site
  • Hôpital Lariboisière
    Paris, Ile-de-France 75010, France
08

References and documents

Publications

  • Lopes A, Mougari F, Chopin D, Pogliaghi M, Munier AL, Delcey V, Simoneau G, Raskine L, Evans J, Mouly S, Cambau E, Bergmann JF, Sellier P. Prospective study comparing the conventional and same-day strategies to diagnose pulmonary tuberculosis. Med Mal Infect. 2020 Feb;50(1):36-42. doi: 10.1016/j.medmal.2019.03.010. Epub 2019 Apr 11. PubMed 30982671 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02961569
Lead sponsor
Hopital Lariboisière
Responsible party
Célia Lloret-Linares, MD PhD (Principal Investigator, Hopital Lariboisière) — Principal investigator
First posted
Nov 11, 2016
Start date
Jul 2016
Primary completion
Apr 2017
Completion
Apr 2017
Last update
Apr 28, 2017

Study contacts

Célia Lloret-Linares, MD, PhD
principal investigator · Unité de Recherches Thérapeutiques, Hôpital Lariboisière

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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