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

NCT03822156 | Completed

• 2 other identifiers: UUlsanKCT0003707
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (5)

• TLSD

  Treatment of anti-TB medication to Last Smear positive Duration

  at baseline

• TLCD

  Treatment of anti-TB medication to Last Culture positive Duration

  at baseline

• ACSD

  AFB Culture-Smear positive Dissociation

  at baseline

• TCV/RLV

  TCV/RLV (Total Cavity\[ies\] Volume/Total Lung Volume) on enhance CT

  at baseline

• TTV/RLV

  TTV/RLV (Total TB lesion Volume/Total Lung Volume) on enhance CT

  at baseline

Secondary Outcomes (5)

• Radiological measure for Tb lesions including cavity size, number

  at baseline

• Admission Duration

  at baseline

• Isolation Duration

  at baseline

• Hemoptysis /Bronchial artery embolization (BAE)

  at baseline

• TB PCR, XPERT

  at baseline

Study Arms (2)

Cavitary Pulmonary Tuberculosis

The patients who are diagnosed with the cavitary pulmonary tuberculosis

Other: Observation of AFB smear/culture

Endobronchial Tuberculosis

The patients who are diagnosed with the endobronchial tuberculosis

Other: Observation of AFB smear/culture

Interventions

Observation of AFB smear/culture OTHER

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

Cavitary Pulmonary Tuberculosis; Endobronchial Tuberculosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Aged 18 years and older
• The patient who has the cavitary pulmonary TB

You may not qualify if:

• Age \< 18 years
• Any Malignant patient
• Patients with bacterial or viral or fungal pneumonia based on the judgment of the attending physician
• Patients who had a history of any pulmonary cystic lesion such as infected bulla, bullous emphysema
• 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
• Patients who were diagnosed with bronchiectasis
• Patients who were diagnosed with NTM-PD (non-tuberculous mycobacterial pulmonary disease) or any documented culture of NTM from a bronchial sample including sputum
• Patients who were diagnosed with connective tissue disease such as Wegener's granulomatosis, SLE
• Patients who were diagnosed with TB destroyed lung
• Patients who were diagnosed with congenital lung disease such as Congenital Cystic Adenomatoid Malformation (CCAM), pulmonary sequestration
• Patients who were diagnosed with interstitial lung disease such as Lymphangioleiomyomatosis (LAM), idiopathic pulmonary fibrosis (IPF)
• Patients who were diagnosed with culture-negative pulmonary TB
• Patients who did not take anti-TB medication more than twice a week on average
• Patients who were diagnosed with sarcoidosis
• Patients who were diagnosed with paragonimiasis

Sponsors & Collaborators

• University of Ulsan: lead
• Ulsan University Hospital: collaborator

Study Sites (1)

Ulsan University Hospital, 877 Bangeojin Sunwhando-ro

Ulsan, 44033, South Korea

Location

MeSH Terms

Conditions

Tuberculosis; Tuberculosis, Pulmonary; Tuberculosis, Multidrug-Resistant

Interventions

Culture Techniques

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

In Vitro Techniques; Investigative Techniques

Study Officials

• Kwang Won Seo, M.D., Ph.D.

  Ulsan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, division of pulmonology, dept. of internal medicine

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: January 30, 2019
• Study Start: January 1, 2010
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: June 25, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)