Back to resultsComparison Between Two Strategies for the Diagnosis of TB
Primary Purpose
Pulmonary TB
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sputum collection for acid fast bacilli
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary TB
Eligibility 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
Sites / Locations
- Hôpital Lariboisière
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
One open-label arm
Arm Description
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)
Outcomes
Primary Outcome Measures
Comparison between the sensitivities of the two strategies for detection of Acid fast bacilli (AFB) on direct stain
Ziehl Neelsen
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02961569
Brief Title
Comparison Between Two Strategies for the Diagnosis of TB
Official Title
Comparative Study Between the Classical Strategy and a Faster, Daily Collection for the Diagnosis of Contagious Pulmonary Tuberculosis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hopital Lariboisière
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary TB
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
One open-label arm
Arm Type
Other
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
sputum collection for acid fast bacilli
Intervention Description
spontaneous or post fiberoptic bronchoscopy sputa
Primary Outcome Measure Information:
Title
Comparison between the sensitivities of the two strategies for detection of Acid fast bacilli (AFB) on direct stain
Description
Ziehl Neelsen
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Célia Lloret-Linares, MD, PhD
Organizational Affiliation
Unité de Recherches Thérapeutiques, Hôpital Lariboisière
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Lariboisière
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75010
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30982671
Citation
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.
Results Reference
derived
Learn more about this trial
Comparison Between Two Strategies for the Diagnosis of TB
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