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CompletedNCT03822156Updated Jun 25, 2019

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

An observational study in Tuberculosis, Tuberculosis, Pulmonary and Cavity, sponsored by University of Ulsan. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-25.

Sponsored by University of Ulsan · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Tuberculosis
  • Tuberculosis, Pulmonary
  • Cavity
  • Bronchoscopy
  • Acid Fast Bacilli Infection
  • Multi-drug Resistant Tuberculosis
  • Transmission
  • Insolation

Keywords

  • Cavitary Pulmonary Tuberculosis
  • Acid fast bacilli (AFB)
  • Isolation
  • Endobronchial Tuberculosis
  • Transmission
  • Drug susceptible test (DST)
  • Ant-tuberculous agent
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Eligibility criteria

A. Cavitary Pulmonary TB Group

Inclusion Criteria:

  1. Aged 18 years and older
  2. The patient who has the cavitary pulmonary TB

Exclusion Criteria:

  1. Age \< 18 years
  2. Any Malignant patient
  3. Patients with bacterial or viral or fungal pneumonia based on the judgment of the attending physician
  4. Patients who had a history of any pulmonary cystic lesion such as infected bulla, bullous emphysema
  5. 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
  6. Patients who were diagnosed with bronchiectasis
  7. Patients who were diagnosed with NTM-PD (non-tuberculous mycobacterial pulmonary disease) or any documented culture of NTM from a bronchial sample including sputum
  8. Patients who were diagnosed with connective tissue disease such as Wegener's granulomatosis, SLE
  9. Patients who were diagnosed with TB destroyed lung
  10. Patients who were diagnosed with congenital lung disease such as Congenital Cystic Adenomatoid Malformation (CCAM), pulmonary sequestration
  11. Patients who were diagnosed with interstitial lung disease such as Lymphangioleiomyomatosis (LAM), idiopathic pulmonary fibrosis (IPF)
  12. Patients who were diagnosed with culture-negative pulmonary TB
  13. Patients who did not take anti-TB medication more than twice a week on average
  14. Patients who were diagnosed with sarcoidosis
  15. Patients who were diagnosed with paragonimiasis
  16. Patients who were diagnosed with pulmonary thromboembolism due to excluding pulmonary infarction
  17. The patient who did not consent
  18. Patients who were diagnosed with MDR/XDR TB through AFB culture

B. Endobronchial TB Group

Inclusion Criteria:

  1. Aged 18 years and older
  2. The patient who has the endobronchial TB through bronchoscopy

Exclusion Criteria:

  1. Age \< 18 years
  2. Patient who was not consented
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (actual)
Target follow-up
8 Years
Patient registry
Yes

Groups and cohorts

  • Cavitary Pulmonary Tuberculosis

    The patients who are diagnosed with the cavitary pulmonary tuberculosis

    Other: Observation of AFB smear/culture

  • Endobronchial Tuberculosis

    The patients who are diagnosed with the endobronchial tuberculosis

    Other: Observation of AFB smear/culture

Interventions

  • OtherObservation of AFB smear/culture

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

05

What researchers measure

Primary outcomes

  1. TLSD

    Treatment of anti-TB medication to Last Smear positive Duration

    Time frame: at baseline

  2. TLCD

    Treatment of anti-TB medication to Last Culture positive Duration

    Time frame: at baseline

  3. ACSD

    AFB Culture-Smear positive Dissociation

    Time frame: at baseline

  4. TCV/RLV

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

    Time frame: at baseline

  5. TTV/RLV

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

    Time frame: at baseline

Secondary outcomes

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

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

    Time frame: at baseline

  2. Admission Duration

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

    Time frame: at baseline

  3. Isolation Duration

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

    Time frame: at baseline

  4. Hemoptysis /Bronchial artery embolization (BAE)

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

    Time frame: at baseline

  5. TB PCR, XPERT

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

    Time frame: at baseline

06

Study locations

1 site
  • Ulsan University Hospital, 877 Bangeojin Sunwhando-ro
    Ulsan, 44033, Korea, Republic of
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03822156
Lead sponsor
University of Ulsan
Collaborators
Ulsan University Hospital
Responsible party
Kwang Won Seo (Associate professor, division of pulmonology, dept. of internal medicine, University of Ulsan) — Principal investigator
First posted
Jan 30, 2019
Start date
Jan 1, 2010
Primary completion
Jun 30, 2018
Completion
Jun 30, 2018
Last update
Jun 25, 2019

Study contacts

Kwang Won Seo, M.D., Ph.D.
principal investigator · Ulsan University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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