Induced Sputum Versus Bronchoscopy in Smear Negative Pulmonary Tuberculosis

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014