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

Tuberculosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03822156
• Other study ID #: UUlsan
• Secondary ID: KCT0003707
• Status: Completed
• Start date: January 1, 2010
• Est. completion date: June 30, 2018

Study information

• Verified date: June 2019
• Source: University of Ulsan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Ulsan University Hospital, 877 Bangeojin Sunwhando-ro	Ulsan

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulsan	Ulsan University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TLSD	Treatment of anti-TB medication to Last Smear positive Duration	at baseline
Primary	TLCD	Treatment of anti-TB medication to Last Culture positive Duration	at baseline
Primary	ACSD	AFB Culture-Smear positive Dissociation	at baseline
Primary	TCV/RLV	TCV/RLV (Total Cavity[ies] Volume/Total Lung Volume) on enhance CT	at baseline
Primary	TTV/RLV	TTV/RLV (Total TB lesion Volume/Total Lung Volume) on enhance CT	at baseline
Secondary	Radiological measure for Tb lesions including cavity size, number	analysis by BioView Duet Workstation (BioView Ltd, Rehovot, Israel) [cavitary pulmonary TB]	at baseline
Secondary	Admission Duration	The patients' Hospital admission duration [cavitary pulmonary TB and endobronchial TB]	at baseline
Secondary	Isolation Duration	The patients' isolation duration during hospital admission [cavitary pulmonary TB and endobronchial TB]	at baseline
Secondary	Hemoptysis /Bronchial artery embolization (BAE)	The patients' history of Hemoptysis /Bronchial artery embolization (BAE) [cavitary pulmonary TB and endobronchial TB]	at baseline
Secondary	TB PCR, XPERT	The patients' result of TB PCR, XPERT [cavitary pulmonary TB and endobronchial TB]	at baseline