Induced Sputum Versus Bronchoscopy in Smear Negative Pulmonary Tuberculosis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pulmonary Tuberculosis

Intervention / Treatment
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* Procedure: Diagnostic techniques in pulmonary tuberculosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endoscopic approach<br>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. | Procedure: Diagnostic techniques in pulmonary tuberculosis<br>* Two different methods to obtain a diagnosis of pulmonary tuberculosis in patients with negative classic sputum samples are compared.<br>* Other names: Sputum induction;|
| Active Comparator: Induced sputum<br>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. | Procedure: Diagnostic techniques in pulmonary tuberculosis<br>* Two different methods to obtain a diagnosis of pulmonary tuberculosis in patients with negative classic sputum samples are compared.<br>* Other names: Sputum induction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensibility of diagnosis of tuberculosis (positive culture and/or PCR) |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary tuberculosis, negative sputum exam, induced sputum, endoscopy