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

October 5, 2009
October 10, 2013
August 2009
January 2015   (final data collection date for primary outcome measure)
Sensibility of diagnosis of tuberculosis (positive culture and/or PCR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01011543 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Induced Sputum Versus Bronchoscopy in Smear Negative Pulmonary Tuberculosis
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

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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Pulmonary Tuberculosis
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: 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.
    Intervention: Procedure: Diagnostic techniques in pulmonary tuberculosis
  • 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.
    Intervention: Procedure: Diagnostic techniques in pulmonary tuberculosis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
154
April 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Inge M Muylle (0032)25353368 Inge_MUYLLE@stpierre-bru.be
Contact: Vincent Ninane (0032)25354276 Vincent_NINANE@stpierre-bru.be
Belgium
 
NCT01011543
B07620096009
No
Centre Hospitalier Universitaire Saint Pierre
Centre Hospitalier Universitaire Saint Pierre
Not Provided
Principal Investigator: Inge M Muylle CHU St Pierre Brussels
Centre Hospitalier Universitaire Saint Pierre
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP