TuberculosisNCT03822156
Clinical Analysis of the Patients With Cavitary Pulmonary TB and Endobronchial TB in the PPM-UUH Cohort
An observational study of Tuberculosis and Tuberculosis, Pulmonary, run by University of Ulsan at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Tuberculosis, Pulmonary, Cavity
- What is being tested?
- Observation of AFB smear/culture
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2010to 30 Jun 2018
- How long will I take part?
- 8 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Aged 18 years and older
- The patient who has the cavitary pulmonary TB
- Aged 18 years and older
- The patient who has the endobronchial TB through bronchoscopy
Who cannot join
- 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
Show all 21Show fewer
- 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
- Patients who were diagnosed with pulmonary thromboembolism due to excluding pulmonary infarction
- The patient who did not consent
- Patients who were diagnosed with MDR/XDR TB through AFB culture
- Endobronchial TB Group
- Age < 18 years
- Patient who was not consented
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Ulsan University Hospital, 877 Bangeojin Sunwhando-ro
Ulsan, 44033
About this study
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)
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.
Read the 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
- Being tested
- Observation of AFB smear/culture
- Keywords
- Cavitary Pulmonary Tuberculosis, Acid fast bacilli (AFB), Isolation, Endobronchial Tuberculosis, Transmission, Drug susceptible test (DST), Ant-tuberculous agent
- Medical subject headings
- Tuberculosis, Tuberculosis, Pulmonary, Tuberculosis, Multidrug-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of AFB smear/cultureOther
Observation of the patients from group for their AFB smear/culture results
| Study group | Role | What they receive |
|---|---|---|
| Cavitary Pulmonary Tuberculosis | The patients who are diagnosed with the cavitary pulmonary tuberculosis Receives: Other: Observation of AFB smear/culture | |
| Endobronchial Tuberculosis | The patients who are diagnosed with the endobronchial tuberculosis Receives: Other: Observation of AFB smear/culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
TLSD
Treatment of anti-TB medication to Last Smear positive Duration
Measured: at baseline
TLCD
Treatment of anti-TB medication to Last Culture positive Duration
Measured: at baseline
ACSD
AFB Culture-Smear positive Dissociation
Measured: at baseline
TCV/RLV
TCV/RLV (Total Cavity[ies] Volume/Total Lung Volume) on enhance CT
Measured: at baseline
TTV/RLV
TTV/RLV (Total TB lesion Volume/Total Lung Volume) on enhance CT
Measured: at baseline
Secondary outcomes (5)
Radiological measure for Tb lesions including cavity size, number
analysis by BioView Duet Workstation (BioView Ltd, Rehovot, Israel) [cavitary pulmonary TB]
Measured: at baseline
Admission Duration
The patients' Hospital admission duration [cavitary pulmonary TB and endobronchial TB]
Measured: at baseline
Isolation Duration
The patients' isolation duration during hospital admission [cavitary pulmonary TB and endobronchial TB]
Measured: at baseline
Hemoptysis /Bronchial artery embolization (BAE)
The patients' history of Hemoptysis /Bronchial artery embolization (BAE) [cavitary pulmonary TB and endobronchial TB]
Measured: at baseline
TB PCR, XPERT
The patients' result of TB PCR, XPERT [cavitary pulmonary TB and endobronchial TB]
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start1 Jan 2010
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 8 Years
Sponsor and investigators
- Lead sponsor
- University of Ulsan
- Sponsor type
- University, hospital or other
- Collaborators
- Ulsan University Hospital
- Responsible party
- Principal investigator, Kwang Won Seo, University of Ulsan
- Investigators
- Kwang Won Seo, M.D., Ph.D., Principal investigator, Ulsan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822156
- Sponsor's protocol ID
- UUlsan
- Other IDs
- KCT0003707
- Status last verified
- Jun 2019
- First submitted
- 25 Jan 2019
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03822156
- Acronym / sponsor ID
- UUlsan
- Conditions
- Tuberculosis, Tuberculosis, Pulmonary, Cavity, Bronchoscopy, Acid Fast Bacilli Infection, Multi-drug Resistant Tuberculosis
- Keywords
- Cavitary Pulmonary Tuberculosis, Acid fast bacilli (AFB), Isolation, Endobronchial Tuberculosis, Transmission, Drug susceptible test (DST), Ant-tuberculous agent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of UlsanUniversity, hospital or other
- Collaborators
- Ulsan University Hospital
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cavitary Pulmonary Tuberculosis | – | Other: Observation of AFB smear/cultureThe patients who are diagnosed with the cavitary pulmonary tuberculosis |
| Endobronchial Tuberculosis | – | Other: Observation of AFB smear/cultureThe patients who are diagnosed with the endobronchial tuberculosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Aged 18 years and older
- The patient who has the cavitary pulmonary TB
- Aged 18 years and older
- The patient who has the endobronchial TB through bronchoscopy
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation of AFB smear/cultureObservation of the patients from group for their AFB smear/culture results | Other | Cavitary Pulmonary Tuberculosis, Endobronchial Tuberculosis |
Primary outcome
TLSD
Time frame: at baseline
Treatment of anti-TB medication to Last Smear positive Duration
TLCD
Time frame: at baseline
Treatment of anti-TB medication to Last Culture positive Duration
ACSD
Time frame: at baseline
AFB Culture-Smear positive Dissociation
TCV/RLV
Time frame: at baseline
TCV/RLV (Total Cavity[ies] Volume/Total Lung Volume) on enhance CT
TTV/RLV
Time frame: at baseline
TTV/RLV (Total TB lesion Volume/Total Lung Volume) on enhance CT
5 secondary outcomes
Radiological measure for Tb lesions including cavity size, number
Time frame: at baseline
Admission Duration
Time frame: at baseline
Isolation Duration
Time frame: at baseline
Hemoptysis /Bronchial artery embolization (BAE)
Time frame: at baseline
TB PCR, XPERT
Time frame: at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwang Won Seo, M.D., Ph.D. principal investigator
Ulsan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and Tuberculosis, Pulmonary, run by University of Ulsan at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TLSD (time frame: at baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.