Induced Sputum Versus Bronchoscopy in Smear Negative Pulmonary Tuberculosis

NCT01011543 | Completed

• 1 other identifier: B07620096009
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Tuberculosis

Keywords

pulmonary tuberculosis; negative sputum exam; induced sputum; endoscopy

Outcome Measures

Primary Outcomes (1)

• Sensibility of diagnosis of tuberculosis (positive culture and/or PCR)

  12 weeks

Study Arms (2)

Endoscopic approach

ACTIVE COMPARATOR

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

Induced sputum

ACTIVE COMPARATOR

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

Interventions

Diagnostic techniques in pulmonary tuberculosis PROCEDURE

Two different methods to obtain a diagnosis of pulmonary tuberculosis in patients with negative classic sputum samples are compared.

Also known as: Bronchoscopy, Fluoroscopy-guided bronchoscopy, Bronchoalveolar lavage, Sputum induction

Endoscopic approach; Induced sputum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient suspected of pulmonary tuberculosis with 3 consecutive (non-induced) sputum samples negative on direct exam and PCR.

You may not qualify if:

• Age \< 18
• Pregnancy
• Actual asthma exacerbation
• Participation to study refused by patient

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

CHU St Pierre; pulmonology department

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Interventions

Bronchoscopy; Bronchoalveolar Lavage

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Therapeutic Irrigation; Investigative Techniques

Study Officials

• Inge M Muylle

  CHU St Pierre Brussels

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2009
• First Posted: November 11, 2009
• Study Start: August 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 3, 2018

Record last verified: 2015-08

Locations

BE (1)