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

NCT ID: NCT03822156

Last Updated: 2019-06-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-01
• Study Completion Date: 2018-06-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cavitary Pulmonary Tuberculosis

The patients who are diagnosed with the cavitary pulmonary tuberculosis

Observation of AFB smear/culture

Intervention Type: OTHER

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

Endobronchial Tuberculosis

The patients who are diagnosed with the endobronchial tuberculosis

Observation of AFB smear/culture

Intervention Type: OTHER

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

Interventions

Observation of AFB smear/culture

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Aged 18 years and older

2. The patient who has the cavitary pulmonary TB

1. Aged 18 years and older

2. The patient who has the endobronchial TB through bronchoscopy

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

1. Age < 18 years

2. Patient who was not consented

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ulsan University Hospital

OTHER

Sponsor Role: collaborator

University of Ulsan

OTHER

Sponsor Role: lead

Responsible Party

Kwang Won Seo

Associate professor, division of pulmonology, dept. of internal medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kwang Won Seo, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ulsan University Hospital

Locations

Ulsan University Hospital, 877 Bangeojin Sunwhando-ro

Ulsan, , South Korea

Countries

South Korea

Other Identifiers

KCT0003707

Identifier Type: OTHER

Identifier Source: secondary_id

UUlsan

Identifier Type: -

Identifier Source: org_study_id