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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01011543
Other study ID # B07620096009
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2009
Est. completion date December 2015

Study information

Verified date August 2015
Source Centre Hospitalier Universitaire Saint Pierre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

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.

Locations

Country Name City State
Belgium CHU St Pierre; pulmonology department Brussels

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensibility of diagnosis of tuberculosis (positive culture and/or PCR) 12 weeks
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