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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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03822156
Enrollment
500
Registered
2019-01-30
Start date
2010-01-01
Completion date
2018-06-30
Last updated
2019-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

OTHERObservation of AFB smear/culture

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

Sponsors

Ulsan University Hospital
CollaboratorOTHER
University of Ulsan
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
TTV/RLVat baselineTTV/RLV (Total TB lesion Volume/Total Lung Volume) on enhance CT
TLSDat baselineTreatment of anti-TB medication to Last Smear positive Duration
TLCDat baselineTreatment of anti-TB medication to Last Culture positive Duration
ACSDat baselineAFB Culture-Smear positive Dissociation
TCV/RLVat baselineTCV/RLV (Total Cavity\[ies\] Volume/Total Lung Volume) on enhance CT

Secondary

MeasureTime frameDescription
Radiological measure for Tb lesions including cavity size, numberat baselineanalysis by BioView Duet Workstation (BioView Ltd, Rehovot, Israel) \[cavitary pulmonary TB\]
Admission Durationat baselineThe patients' Hospital admission duration \[cavitary pulmonary TB and endobronchial TB\]
Isolation Durationat baselineThe patients' isolation duration during hospital admission \[cavitary pulmonary TB and endobronchial TB\]
Hemoptysis /Bronchial artery embolization (BAE)at baselineThe patients' history of Hemoptysis /Bronchial artery embolization (BAE) \[cavitary pulmonary TB and endobronchial TB\]
TB PCR, XPERTat baselineThe patients' result of TB PCR, XPERT \[cavitary pulmonary TB and endobronchial TB\]

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026