Induced Sputum Versus Bronchoscopy in Smear Negative Pulmonary Tuberculosis
- Conditions
- Pulmonary Tuberculosis
- Registration Number
- NCT01011543
- Lead Sponsor
- Centre Hospitalier Universitaire Saint Pierre
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- Patient suspected of pulmonary tuberculosis with 3 consecutive (non-induced) sputum samples negative on direct exam and PCR.
- Age < 18
- Pregnancy
- Actual asthma exacerbation
- Participation to study refused by patient
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Sensibility of diagnosis of tuberculosis (positive culture and/or PCR) 12 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CHU St Pierre; pulmonology department
🇧🇪Brussels, Belgium
CHU St Pierre; pulmonology department🇧🇪Brussels, Belgium