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

Completed

• Conditions: Transmission; Tuberculosis, Pulmonary; Insolation; Bronchoscopy; Acid Fast Bacilli Infection; Multi-drug Resistant Tuberculosis; Tuberculosis; Cavity
• Interventions: Other: Observation of AFB smear/culture

• Registration Number: NCT03822156
• Lead Sponsor: University of Ulsan

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.

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 Timeline

• Study Start: 2010-01-01
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Study First Submitted: 2019-01-25
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-30
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-23
• Last Update Posted: 2019-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cavitary Pulmonary Tuberculosis	Observation of AFB smear/culture	The patients who are diagnosed with the cavitary pulmonary tuberculosis
Endobronchial Tuberculosis	Observation of AFB smear/culture	The patients who are diagnosed with the endobronchial tuberculosis

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ulsan University Hospital, 877 Bangeojin Sunwhando-ro; 🇰🇷 Ulsan, Korea, Republic of