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Clinical Trials/NCT01011543
NCT01011543
Completed
Not Applicable

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

Centre Hospitalier Universitaire Saint Pierre1 site in 1 country160 target enrollmentAugust 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Tuberculosis
Sponsor
Centre Hospitalier Universitaire Saint Pierre
Enrollment
160
Locations
1
Primary Endpoint
Sensibility of diagnosis of tuberculosis (positive culture and/or PCR)
Status
Completed
Last Updated
7 years ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
August 2009
End Date
December 2015
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centre Hospitalier Universitaire Saint Pierre
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Time Frame: 12 weeks

Study Sites (1)

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