跳至主要内容
临床试验/NCT01011543
NCT01011543已完成不适用

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

Centre Hospitalier Universitaire Saint Pierre2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2009年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
160
试验地点
2
主要终点
Sensibility of diagnosis of tuberculosis (positive culture and/or PCR)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

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.

干预措施: Diagnostic techniques in pulmonary tuberculosis (Procedure)

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.

干预措施: Diagnostic techniques in pulmonary tuberculosis (Procedure)

结局指标

主要结局

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

时间窗: 12 weeks

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Universitaire Saint Pierre
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验