Comparison Between Two Strategies for the Diagnosis of TB
Comparative Study Between the Classical Strategy and a Faster, Daily Collection for the Diagnosis of Contagious Pulmonary Tuberculosis
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 18, 2016
CompletedFirst Posted
Study publicly available on registry
November 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedApril 28, 2017
April 1, 2017
9 months
October 18, 2016
April 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison between the sensitivities of the two strategies for detection of Acid fast bacilli (AFB) on direct stain
Ziehl Neelsen
one year
Study Arms (1)
One open-label arm
OTHERPatients 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)
Interventions
spontaneous or post fiberoptic bronchoscopy sputa
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Patients who refused or were unable to give written consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Lariboisière
Paris, Île-de-France Region, 75010, France
Related Publications (1)
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.
PMID: 30982671DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Célia Lloret-Linares, MD, PhD
Unité de Recherches Thérapeutiques, Hôpital Lariboisière
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 18, 2016
First Posted
November 11, 2016
Study Start
July 1, 2016
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
April 28, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share