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

Sponsor
University of Ulsan (Other)
Overall Status
Completed
CT.gov ID
NCT03822156
Collaborator
Ulsan University Hospital (Other)
500
1
101.9
4.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Observation of AFB smear/culture

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.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official 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)
Actual Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Jun 30, 2018
Actual Study Completion Date :
Jun 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Cavitary Pulmonary Tuberculosis

The patients who are diagnosed with the cavitary pulmonary tuberculosis

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

Endobronchial Tuberculosis

The patients who are diagnosed with the endobronchial tuberculosis

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

Outcome Measures

Primary Outcome Measures

  1. TLSD [at baseline]

    Treatment of anti-TB medication to Last Smear positive Duration

  2. TLCD [at baseline]

    Treatment of anti-TB medication to Last Culture positive Duration

  3. ACSD [at baseline]

    AFB Culture-Smear positive Dissociation

  4. TCV/RLV [at baseline]

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

  5. TTV/RLV [at baseline]

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

Secondary Outcome Measures

  1. Radiological measure for Tb lesions including cavity size, number [at baseline]

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

  2. Admission Duration [at baseline]

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

  3. Isolation Duration [at baseline]

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

  4. Hemoptysis /Bronchial artery embolization (BAE) [at baseline]

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

  5. TB PCR, XPERT [at baseline]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
  1. 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

  1. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ulsan University Hospital, 877 Bangeojin Sunwhando-ro Ulsan Korea, Republic of 44033

Sponsors and Collaborators

  • University of Ulsan
  • Ulsan University Hospital

Investigators

  • Principal Investigator: Kwang Won Seo, M.D., Ph.D., Ulsan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kwang Won Seo, Associate professor, division of pulmonology, dept. of internal medicine, University of Ulsan
ClinicalTrials.gov Identifier:
NCT03822156
Other Study ID Numbers:
  • UUlsan
  • KCT0003707
First Posted:
Jan 30, 2019
Last Update Posted:
Jun 25, 2019
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kwang Won Seo, Associate professor, division of pulmonology, dept. of internal medicine, University of Ulsan
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 25, 2019