Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03822156
Other study ID # UUlsan
Secondary ID KCT0003707
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05738681 - Efficacy of N-acetylcysteine to Prevent Anti-tuberculosis Drug-induced Liver Injury: A Randomized Controlled Trial Phase 2/Phase 3
Recruiting NCT05526885 - Tuberculosis Diagnostic Trial of CAD4TB Screening Alone Compared to CAD4TB Screening Combined With a CRP Triage Test, Both Followed by Confirmatory Xpert MTB/RIF Ultra in Communities of Lesotho and South Africa N/A
Completed NCT04369326 - Community Initiated Preventive Therapy for TB N/A
Recruiting NCT04568967 - TB-CAPT EXULTANT - HIV N/A
Completed NCT02337270 - Phase 1 Clinical Trial of the Safety and Immunogenicity of an Adenovirus-based TB Vaccine Administered by Aerosol Phase 1
Not yet recruiting NCT06253715 - Shortened Regimen for Drug-susceptible TB in Children Phase 3
Recruiting NCT04271397 - Immunological Biomarkers in Tuberculosis Management N/A
Withdrawn NCT03639038 - Tuberculosis Diagnosis by Flow Cytometry
Completed NCT03199313 - Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sutezolid Phase 1
Recruiting NCT04975178 - Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa Phase 3
Completed NCT04463680 - Rifampin and the Contraceptive Implant Phase 4
Completed NCT03973970 - Assessing the Ability of the T-SPOT®.TB Test (IQ)
Recruiting NCT04230395 - Alcohol Reduction Among People With TB and HIV in India N/A
Completed NCT04874948 - Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment Phase 1
Active, not recruiting NCT02906007 - Evaluating the Pharmacokinetics, Safety, and Tolerability of Bedaquiline in Infants, Children, and Adolescents With Multidrug-Resistant Tuberculosis, Living With or Without HIV Phase 1/Phase 2
Not yet recruiting NCT05917210 - Peer-led Implementation of TB-HIV Education and Adherence Counseling in Uganda N/A
Not yet recruiting NCT05845112 - Start Taking Action For TB Diagnosis
Not yet recruiting NCT06017843 - Impact Evaluation of Use of MATCH AI Predictive Modelling for Identification of Hotspots for TB Active Case Finding N/A
Active, not recruiting NCT02715271 - Study of TB Lesions Obtained in Therapeutical Surgery
Completed NCT02781909 - Potential Efficacy and Safety of Using Adjunctive Ibuprofen for XDR-TB Tuberculosis Phase 2