Clinical trial NCT03822156: Clinical Analysis of the Patients With Cavitary Pulmonary TB and Endobronchial TB in the PPM-UUH Cohort
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Lead sponsor: University of Ulsan
Sponsor class: OTHER
Collaborators: name: Ulsan University Hospital
First posted: 2019-01-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: TLSD
timeFrame: at baseline
measure: TLCD
timeFrame: at baseline
measure: ACSD
timeFrame: at baseline
measure: TCV/RLV
timeFrame: at baseline
measure: TTV/RLV
timeFrame: at baseline
Secondary outcomes:
measure: Radiological measure for Tb lesions including cavity size, number
timeFrame: at baseline
measure: Admission Duration
timeFrame: at baseline
measure: Isolation Duration
timeFrame: at baseline
measure: Hemoptysis /Bronchial artery embolization (BAE)
timeFrame: at baseline
measure: TB PCR, XPERT
timeFrame: at baseline
Other outcomes:
Locations:
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital, 877 Bangeojin Sunwhando-ro
Study officials:
affiliation: Ulsan University Hospital
name: Kwang Won Seo, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: