Comparison Between Two Strategies for the Diagnosis of TB

Pulmonary TB Clinical Trial

Official title:

Comparative Study Between the Classical Strategy and a Faster, Daily Collection for the Diagnosis of Contagious Pulmonary Tuberculosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02961569
• Other study ID #: TBsputum
• Status: Completed
• Phase: N/A
• First received: October 18, 2016
• Last updated: April 26, 2017
• Start date: July 2016
• Est. completion date: April 2017

Study information

• Verified date: April 2017
• Source: Hopital Lariboisière
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary TB
• Tuberculosis, Pulmonary

Intervention

Procedure:
• sputum collection for acid fast bacilli
spontaneous or post fiberoptic bronchoscopy sputa

Locations

Country	Name	City	State
France	Hôpital Lariboisière	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Lariboisière

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison between the sensitivities of the two strategies for detection of Acid fast bacilli (AFB) on direct stain	Ziehl Neelsen	one year