Induced Sputum Versus Bronchoscopy in Smear Negative Pulmonary Tuberculosis

This study is currently recruiting participants.
Verified October 2013 by Centre Hospitalier Universitaire Saint Pierre
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier:
NCT01011543
First received: October 5, 2009
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

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.

Condition Intervention
Pulmonary Tuberculosis
Procedure: Diagnostic techniques in pulmonary tuberculosis

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Saint Pierre:

Primary Outcome Measures:
  • Sensibility of diagnosis of tuberculosis (positive culture and/or PCR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 154
Study Start Date: August 2009
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Endoscopic approach
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.
Procedure: Diagnostic techniques in pulmonary tuberculosis
Two different methods to obtain a diagnosis of pulmonary tuberculosis in patients with negative classic sputum samples are compared.
Other Names:
  • Bronchoscopy
  • Fluoroscopy-guided bronchoscopy
  • Bronchoalveolar lavage
  • Sputum induction
Active Comparator: Induced sputum
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.
Procedure: Diagnostic techniques in pulmonary tuberculosis
Two different methods to obtain a diagnosis of pulmonary tuberculosis in patients with negative classic sputum samples are compared.
Other Names:
  • Bronchoscopy
  • Fluoroscopy-guided bronchoscopy
  • Bronchoalveolar lavage
  • Sputum induction

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01011543

Contacts
Contact: Inge M Muylle (0032)25353368 Inge_MUYLLE@stpierre-bru.be
Contact: Vincent Ninane (0032)25354276 Vincent_NINANE@stpierre-bru.be

Locations
Belgium
CHU St Pierre; pulmonology department Recruiting
Brussels, Belgium, 1000
Contact: Inge M Muylle    (0032)25354295    Inge_MUYLLE@stpierre-bru.be   
Contact: Vincent Ninane    (0032)25354276    Vincent_NINANE@stpierre-bru.be   
Principal Investigator: Inge M Muylle         
Sponsors and Collaborators
Centre Hospitalier Universitaire Saint Pierre
Investigators
Principal Investigator: Inge M Muylle CHU St Pierre Brussels
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier: NCT01011543     History of Changes
Other Study ID Numbers: B07620096009
Study First Received: October 5, 2009
Last Updated: October 10, 2013
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Keywords provided by Centre Hospitalier Universitaire Saint Pierre:
pulmonary tuberculosis
negative sputum exam
induced sputum
endoscopy

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 17, 2014