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Induced Sputum Versus Bronchoscopy in Smear Negative Pulmonary Tuberculosis

Primary Purpose

Pulmonary Tuberculosis

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Diagnostic techniques in pulmonary tuberculosis
Sponsored by
Centre Hospitalier Universitaire Saint Pierre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Tuberculosis focused on measuring pulmonary tuberculosis, negative sputum exam, induced sputum, endoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient suspected of pulmonary tuberculosis with 3 consecutive (non-induced) sputum samples negative on direct exam and PCR.

Exclusion Criteria:

  • Age < 18
  • Pregnancy
  • Actual asthma exacerbation
  • Participation to study refused by patient

Sites / Locations

  • CHU St Pierre; pulmonology department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Endoscopic approach

Induced sputum

Arm Description

CT thorax is done in all patients to localize the exact anatomical site of the disease. This evaluation is followed by fluoroscopy-guided bronchoscopy for BAL (bronchoalveolar lavage) and TBB (transbronchial biopsies). A sputum sample immediately after the endoscopy will be collected if possible.

Sputum induction after administration of 6-8 mL 3% NaCl aerosol by an ultrasonic nebulizer; sputum will be collected 15-30 minutes after administration of the aerosol. This process will be done twice in every patient.

Outcomes

Primary Outcome Measures

Sensibility of diagnosis of tuberculosis (positive culture and/or PCR)

Secondary Outcome Measures

Full Information

First Posted
October 5, 2009
Last Updated
August 2, 2018
Sponsor
Centre Hospitalier Universitaire Saint Pierre
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1. Study Identification

Unique Protocol Identification Number
NCT01011543
Brief Title
Induced Sputum Versus Bronchoscopy in Smear Negative Pulmonary Tuberculosis
Official Title
Comparison of Induced Sputum and Bronchoscopic Approach (BAL, Fluoroscopy-guided Transbronchial Biopsies) in Patients Suspected of Pulmonary Tuberculosis With Negative Direct Exam on Three Consecutive Non-induced Sputum Samples
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Saint Pierre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomised study that compares different diagnostic approaches for diagnosing pulmonary tuberculosis in patients suspected of pulmonary tuberculosis in whom the three classic (non-induced) sputum samples didn't show tuberculous bacillus on direct examination. The investigators compare the sensibility of induced sputum technique with an endoscopic approach (CT-scan followed by BAL and fluoroscopy-guided transbronchial biopsies and eventually sputum collection immediately after the bronchoscopy). People in high risk population for tuberculosis undergoing screening by chest X-ray or symptomatic patients will be admitted to the hospital if their chest X-ray shows a suspicion of active tuberculosis. According good clinical practice: (non-induced) sputum samples will be taken at admission and every following morning. If direct examination and PCR of the first three classic sputum samples are negative: patients will be randomised in two groups with a different diagnostic approach (induced sputum versus endoscopic approach) The aim of our study is to proof that a thoroughgoing endoscopic approach has a higher sensibility than an induced sputum in the diagnosis of pulmonary tuberculosis in patients with a high suspicion of active tuberculosis on the chest X-ray but with a negative direct examination and/or PCR on three consecutive normal sputum samples. The investigators will include 154 patients (based on a statistical analysis for a hypothesis that the endoscopic approach has a sensibility that's twice the sensibility of the induced sputum). first arm: 2 consecutive induced sputum using an ultrasonic nebulizer. second arm: CT thorax to evaluate the exact anatomic localisation of the disease followed by fluoroscopy-guided bronchoscopy for BAL (bronchoalveolar lavage) and transbronchial biopsies. A sputum sample immediately after the endoscopy will be collected if possible.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Tuberculosis
Keywords
pulmonary tuberculosis, negative sputum exam, induced sputum, endoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic approach
Arm Type
Active Comparator
Arm Description
CT thorax is done in all patients to localize the exact anatomical site of the disease. This evaluation is followed by fluoroscopy-guided bronchoscopy for BAL (bronchoalveolar lavage) and TBB (transbronchial biopsies). A sputum sample immediately after the endoscopy will be collected if possible.
Arm Title
Induced sputum
Arm Type
Active Comparator
Arm Description
Sputum induction after administration of 6-8 mL 3% NaCl aerosol by an ultrasonic nebulizer; sputum will be collected 15-30 minutes after administration of the aerosol. This process will be done twice in every patient.
Intervention Type
Procedure
Intervention Name(s)
Diagnostic techniques in pulmonary tuberculosis
Other Intervention Name(s)
Bronchoscopy, Fluoroscopy-guided bronchoscopy, Bronchoalveolar lavage, Sputum induction
Intervention Description
Two different methods to obtain a diagnosis of pulmonary tuberculosis in patients with negative classic sputum samples are compared.
Primary Outcome Measure Information:
Title
Sensibility of diagnosis of tuberculosis (positive culture and/or PCR)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient suspected of pulmonary tuberculosis with 3 consecutive (non-induced) sputum samples negative on direct exam and PCR. Exclusion Criteria: Age < 18 Pregnancy Actual asthma exacerbation Participation to study refused by patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inge M Muylle
Organizational Affiliation
CHU St Pierre Brussels
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU St Pierre; pulmonology department
City
Brussels
ZIP/Postal Code
1000
Country
Belgium

12. IPD Sharing Statement

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Induced Sputum Versus Bronchoscopy in Smear Negative Pulmonary Tuberculosis

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