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临床试验/NCT03822156
NCT03822156已完成不适用

Clinical Analysis of the Patients With Cavitary Pulmonary Tuberculosis and Endobronchial Tuberculosis in the Private-Public Mix Project for Tuberculosis, Ulsan University Hospital Cohort (PPM-UUH Cohort)

University of Ulsan1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2010年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
1
主要终点
TTV/RLV

研究概览

简要总结

This study is a retrospective cohort study. The purpose of this study is to investigate clinical features of the patients with the cavitary pulmonary tuberculosis (TB) and endobronchial TB from the patients who have been registered in this hospital for treatment and follow-up, as part of the "PPM Project (Private-Public Mix project) for Korean National Tuberculosis Control" introduced in Korea since 2007.

详细描述

Cavitary pulmonary tuberculosis (TB) is known to remain its Infectivity for a longer period of time than the non-cavitary pulmonary TB, which is usually almost inactivated its infectivity within two weeks after the administration of the anti - TB drugs.

However, there are few studies on this, so it is not known how long the infectivity persists, whether there is a correlation with the number of cavities or the size of the cavities between persistence of infectivity.

Meanwhile, endobronchial TB is known also to be highly infectious, unlike simple pulmonary TB.

It is not known how long infectivity can persist after the administration of anti-TB medication, and whether there is any difference in persistence of infectivity regarding the clinical characteristics of endobronchial TB.

In this study, investigators will analyze the retrospective data analysis of UUH-PPM Cohort, a cohort of PPM project patients in the Ulsan University Hospital (UUH).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Aged 18 years and older
  • The patient who has the cavitary pulmonary TB

排除标准

  • Age < 18 years
  • Any Malignant patient
  • Patients with bacterial or viral or fungal pneumonia based on the judgment of the attending physician
  • Patients who had a history of any pulmonary cystic lesion such as infected bulla, bullous emphysema
  • Patients who were diagnosed with pulmonary fungal infection or previous its history or any documented culture of the fungus from a bronchial sample including sputum
  • Patients who were diagnosed with bronchiectasis
  • Patients who were diagnosed with NTM-PD (non-tuberculous mycobacterial pulmonary disease) or any documented culture of NTM from a bronchial sample including sputum
  • Patients who were diagnosed with connective tissue disease such as Wegener's granulomatosis, SLE
  • Patients who were diagnosed with TB destroyed lung
  • Patients who were diagnosed with congenital lung disease such as Congenital Cystic Adenomatoid Malformation (CCAM), pulmonary sequestration
  • Patients who were diagnosed with interstitial lung disease such as Lymphangioleiomyomatosis (LAM), idiopathic pulmonary fibrosis (IPF)
  • Patients who were diagnosed with culture-negative pulmonary TB
  • Patients who did not take anti-TB medication more than twice a week on average
  • Patients who were diagnosed with sarcoidosis
  • Patients who were diagnosed with paragonimiasis
  • Patients who were diagnosed with pulmonary thromboembolism due to excluding pulmonary infarction
  • The patient who did not consent
  • Patients who were diagnosed with MDR/XDR TB through AFB culture
  • B. Endobronchial TB Group
  • Inclusion Criteria:
  • Aged 18 years and older
  • The patient who has the endobronchial TB through bronchoscopy
  • Exclusion Criteria:
  • Age < 18 years
  • Patient who was not consented

结局指标

主要结局

TTV/RLV

时间窗: at baseline

TTV/RLV (Total TB lesion Volume/Total Lung Volume) on enhance CT

TLCD

时间窗: at baseline

Treatment of anti-TB medication to Last Culture positive Duration

ACSD

时间窗: at baseline

AFB Culture-Smear positive Dissociation

TLSD

时间窗: at baseline

Treatment of anti-TB medication to Last Smear positive Duration

TCV/RLV

时间窗: at baseline

TCV/RLV (Total Cavity\[ies\] Volume/Total Lung Volume) on enhance CT

次要结局

  • Radiological measure for Tb lesions including cavity size, number(at baseline)
  • Admission Duration(at baseline)
  • Isolation Duration(at baseline)
  • Hemoptysis /Bronchial artery embolization (BAE)(at baseline)
  • TB PCR, XPERT(at baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kwang Won Seo

Associate professor, division of pulmonology, dept. of internal medicine

University of Ulsan

研究点 (1)

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