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
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.
Investigators
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