Induced Sputum Versus Bronchoscopy in Smear Negative Pulmonary Tuberculosis

Not Applicable

Completed

• Conditions: Pulmonary Tuberculosis
• Interventions: Procedure: Diagnostic techniques in 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

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-10-05
• Study First Submitted QC: 2009-11-10
• Study First Posted: 2009-11-11
• Status Verified: 2015-08
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2018-08-02
• Last Update Posted: 2018-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endoscopic approach	Diagnostic techniques in pulmonary tuberculosis	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.
Induced sputum	Diagnostic techniques in pulmonary tuberculosis	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.

Primary Outcome Measures

Name	Time	Method
Sensibility of diagnosis of tuberculosis (positive culture and/or PCR)	12 weeks

Trial Locations

Locations (1)

CHU St Pierre; pulmonology department; 🇧🇪 Brussels, Belgium