Pulmonary Tuberculosis
Conditions
Keywords
pulmonary tuberculosis, negative sputum exam, induced sputum, endoscopy
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.
Interventions
Two different methods to obtain a diagnosis of pulmonary tuberculosis in patients with negative classic sputum samples are compared.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensibility of diagnosis of tuberculosis (positive culture and/or PCR) | 12 weeks |
Countries
Belgium