Comparison Between Two Strategies for the Diagnosis of TB

Not Applicable

Completed

• Conditions: Pulmonary TB
• Interventions: Procedure: sputum collection for acid fast bacilli

• Registration Number: NCT02961569
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-11-08
• Study First Posted: 2016-11-11
• Status Verified: 2017-04
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Last Update Submitted: 2017-04-26
• Last Update Posted: 2017-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
One open-label arm	sputum collection for acid fast bacilli	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)

Primary Outcome Measures

Name	Time	Method
Comparison between the sensitivities of the two strategies for detection of Acid fast bacilli (AFB) on direct stain	one year	Ziehl Neelsen

Trial Locations

Locations (1)

Hôpital Lariboisière; 🇫🇷 Paris, Ile-de-France, France