Comparison Between Two Strategies for the Diagnosis of TB

April 26, 2017 updated by: Célia Lloret-Linares, MD PhD, Hopital Lariboisière

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75010
        • Hôpital Lariboisière

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
spontaneous or post fiberoptic bronchoscopy sputa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison between the sensitivities of the two strategies for detection of Acid fast bacilli (AFB) on direct stain
Time Frame: one year
Ziehl Neelsen
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Lariboisière

Investigators

  • Principal Investigator: Célia Lloret-Linares, MD, PhD, Unité de Recherches Thérapeutiques, Hôpital Lariboisière

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

October 18, 2016

First Submitted That Met QC Criteria

November 8, 2016

First Posted (Estimate)

November 11, 2016

Study Record Updates

Last Update Posted (Actual)

April 28, 2017

Last Update Submitted That Met QC Criteria

April 26, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBsputum

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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