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

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)

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.

Study Overview

• Status: Completed
• Conditions: Tuberculosis; Tuberculosis, Pulmonary; Multi-drug Resistant Tuberculosis; Bronchoscopy; Transmission; Cavity; Acid Fast Bacilli Infection; Insolation
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TLSD	Treatment of anti-TB medication to Last Smear positive Duration	at baseline
TLCD	Treatment of anti-TB medication to Last Culture positive Duration	at baseline
ACSD	AFB Culture-Smear positive Dissociation	at baseline
TCV/RLV	TCV/RLV (Total Cavity[ies] Volume/Total Lung Volume) on enhance CT	at baseline
TTV/RLV	TTV/RLV (Total TB lesion Volume/Total Lung Volume) on enhance CT	at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiological measure for Tb lesions including cavity size, number	analysis by BioView Duet Workstation (BioView Ltd, Rehovot, Israel) [cavitary pulmonary TB]	at baseline
Admission Duration	The patients' Hospital admission duration [cavitary pulmonary TB and endobronchial TB]	at baseline
Isolation Duration	The patients' isolation duration during hospital admission [cavitary pulmonary TB and endobronchial TB]	at baseline
Hemoptysis /Bronchial artery embolization (BAE)	The patients' history of Hemoptysis /Bronchial artery embolization (BAE) [cavitary pulmonary TB and endobronchial TB]	at baseline
TB PCR, XPERT	The patients' result of TB PCR, XPERT [cavitary pulmonary TB and endobronchial TB]	at baseline

Collaborators and Investigators

• Sponsor: University of Ulsan
• Collaborators: Ulsan University Hospital
• Investigators: Principal Investigator: Kwang Won Seo, M.D., Ph.D., Ulsan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: January 25, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): June 25, 2019
• Last Update Submitted That Met QC Criteria: June 23, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Transmission; Isolation; Cavitary Pulmonary Tuberculosis; Acid fast bacilli (AFB); Endobronchial Tuberculosis; Drug susceptible test (DST); Ant-tuberculous agent
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Tuberculosis, Pulmonary; Tuberculosis, Multidrug-Resistant
• Other Study ID Numbers: UUlsan; KCT0003707 (Other Identifier: Clinical Research Information Service, Republic of Korea)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No