Induced Sputum Versus Bronchoscopy in Smear Negative Pulmonary Tuberculosis
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pulmonary Tuberculosis |
Procedure: Diagnostic techniques in pulmonary tuberculosis |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | 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 |
- Sensibility of diagnosis of tuberculosis (positive culture and/or PCR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 154 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Endoscopic approach
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
Two different methods to obtain a diagnosis of pulmonary tuberculosis in patients with negative classic sputum samples are compared.
Other Names:
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Active Comparator: Induced sputum
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
Two different methods to obtain a diagnosis of pulmonary tuberculosis in patients with negative classic sputum samples are compared.
Other Names:
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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Inge M Muylle | (0032)25353368 | Inge_MUYLLE@stpierre-bru.be |
| Contact: Vincent Ninane | (0032)25354276 | Vincent_NINANE@stpierre-bru.be |
| Belgium | |
| CHU St Pierre; pulmonology department | Recruiting |
| Brussels, Belgium, 1000 | |
| Contact: Inge M Muylle (0032)25354295 Inge_MUYLLE@stpierre-bru.be | |
| Contact: Vincent Ninane (0032)25354276 Vincent_NINANE@stpierre-bru.be | |
| Principal Investigator: Inge M Muylle | |
| Principal Investigator: | Inge M Muylle | CHU St Pierre Brussels |
More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire Saint Pierre |
| ClinicalTrials.gov Identifier: | NCT01011543 History of Changes |
| Other Study ID Numbers: | B07620096009 |
| Study First Received: | October 5, 2009 |
| Last Updated: | October 11, 2012 |
| Health Authority: | Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment |
Keywords provided by Centre Hospitalier Universitaire Saint Pierre:
|
pulmonary tuberculosis negative sputum exam induced sputum endoscopy |
Additional relevant MeSH terms:
|
Tuberculosis Tuberculosis, Pulmonary Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections |
Bacterial Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 22, 2013