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Completed

NCT Number: NCT03822156

Clinical Analysis of the Patients With Cavitary Pulmonary TB and Endobronchial TB in the PPM-UUH Cohort

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.

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Key information

About this study

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).

The PPM project is a "Private-Public Mix project" for the eradication of tuberculosis from Korea, which the Korean government and private medical institutions have been conducting since 2007.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

A. Cavitary Pulmonary TB Group

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Observation of AFB smear/culture

Other

Observation of the patients from group for their AFB smear/culture results

Primary outcomes

  1. TLSD

    Time frame: at baseline

    Treatment of anti-TB medication to Last Smear positive Duration

  2. TLCD

    Time frame: at baseline

    Treatment of anti-TB medication to Last Culture positive Duration

  3. ACSD

    Time frame: at baseline

    AFB Culture-Smear positive Dissociation

  4. TCV/RLV

    Time frame: at baseline

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

  5. TTV/RLV

    Time frame: at baseline

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

Secondary outcomes

  1. Radiological measure for Tb lesions including cavity size, number

    Time frame: at baseline

    analysis by BioView Duet Workstation (BioView Ltd, Rehovot, Israel) [cavitary pulmonary TB]

  2. Admission Duration

    Time frame: at baseline

    The patients' Hospital admission duration [cavitary pulmonary TB and endobronchial TB]

  3. Isolation Duration

    Time frame: at baseline

    The patients' isolation duration during hospital admission [cavitary pulmonary TB and endobronchial TB]

  4. Hemoptysis /Bronchial artery embolization (BAE)

    Time frame: at baseline

    The patients' history of Hemoptysis /Bronchial artery embolization (BAE) [cavitary pulmonary TB and endobronchial TB]

  5. TB PCR, XPERT

    Time frame: at baseline

    The patients' result of TB PCR, XPERT [cavitary pulmonary TB and endobronchial TB]

Sponsors and collaborators

Lead sponsor

University of Ulsan

Other

Collaborators

  • Ulsan University Hospital

Registry information

Official study title

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)

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Jan 30, 2019
Registry last updated
Jun 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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