Pulmonary TuberculosesNCT05477966
A Retrospective Cohort Study to Develop Markers for TB Severity and Treatment Progress
An observational study of Pulmonary Tuberculoses and Tuberculosis, Pulmonary, run by Jae-Joon Yim at 1 site in South Korea.
Trial summary
The objective of this study is to compare how accurately the Xpert MTB/RIF assay Ct value at diagnosis and the AI-based tuberculosis activity score predict the treatment outcome of rifampin-susceptible pulmonary tuberculosis patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Tuberculoses, Tuberculosis, Pulmonary
- What is being tested?
- Medical records review
- How many people
- 900 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Jul 2022to 18 Jul 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Up to 900 patients diagnosed with rifampin-susceptible pulmonary tuberculosis through the Xpert MTB/RIF assay performed on sputum between January 1, 2019 and December 31, 2019 at the participating institutions
Who may be able to join
- Patients diagnosed with rifampin-susceptible pulmonary tuberculosis by Xpert MTB/RIF assay with sputum samples between January 1, 2019 and December 31, 2019
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University
Seoul, 03080
Jae-Joon Yim, MD, PhD, +82-2-2072-2059, yimjj@snu.ac.kr
About this study
The objective of this study is to compare how accurately the Xpert MTB/RIF assay Ct value at diagnosis and the AI-based tuberculosis activity score predict the treatment outcome of rifampin-susceptible pulmonary tuberculosis patients. As a retrospective observational study, data from patients diagnosed with rifampin susceptible pulmonary tuberculosis through the Xpert MTB/RIF assay performed on sputum in 2019 at the participating institutions will be analyzed (up to 900 people).
- Conditions
- Pulmonary Tuberculoses, Tuberculosis, Pulmonary
- Being tested
- Medical records review
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical records reviewOther
The clinical characteristics at the time of diagnosis of rifampin-susceptible pulmonary tuberculosis patients, the Xpert MTB/RIF assay Ct value, the tuberculosis activity score based on AI of the chest image, and treatment results will be collected retrospectively through medical records.
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative culture conversion until 8 weeks after initiation of treatment
Conversion from positive tuberculosis culture to negative tuberculosis culture
Measured: Within 8 weeks of initiating treatment
Time to negative culture conversion
Time (days) to conversion from positive tuberculosis culture to negative tuberculosis culture
Measured: Within 6 months of initiating treatment
Treatment outcome including 1) Cure 2) Treatment completion 3) Treatment failure 4) Death 5) Loss of follow-up 6) Unknown
- Cure: confirmed negative culture conversion plus negative culture results from at least one sputum on the month of treatment completion
- Treatment completion: confirmed negative culture conversion at least once during treatment
- Treatment failure: positive culture results after 4 months of treatment
- Death: death during treatment
- Loss of follow-up: loss of follow-up during treatment
- Unknown
Measured: Within 2 years of initiating treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start18 Jul 2022 (estimated)
- Primary completion18 Jul 2023 (estimated)
- Study completion18 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary TuberculosesStudies 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
- Retrospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jae-Joon Yim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jae-Joon Yim, Seoul National University Hospital
- Investigators
- Jae-Joon Yim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477966
- Sponsor's protocol ID
- H-2206-179-1336
- Status last verified
- Jul 2022
- First submitted
- 18 Jul 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Cohort Study to Develop Markers for TB Severity and Treatment Progress
- ClinicalTrials.gov ID
- NCT05477966
- Acronym / sponsor ID
- H-2206-179-1336
- Conditions
- Pulmonary Tuberculoses, Tuberculosis, Pulmonary
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Jae-Joon YimUniversity, hospital or other
- Study start
- 18 Jul 2022 (estimated)
- Primary completion
- 18 Jul 2023 (estimated)
- Study completion
- 18 Jul 2023 (estimated)
- First posted
- 28 Jul 2022 (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.
The objective of this study is to compare how accurately the Xpert MTB/RIF assay Ct value at diagnosis and the AI-based tuberculosis activity score predict the treatment outcome of rifampin-susceptible pulmonary tuberculosis patients. As a retrospective observational study, data from patients diagnosed with rifampin susceptible pulmonary tuberculosis through the Xpert MTB/RIF assay performed on sputum in 2019 at the participating institutions will be analyzed (up to 900 people).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Up to 900 patients diagnosed with rifampin-susceptible pulmonary tuberculosis through the Xpert MTB/RIF assay performed on sputum between January 1, 2019 and December 31, 2019 at the participating institutions
Key inclusion criteria (1 listed)
- Patients diagnosed with rifampin-susceptible pulmonary tuberculosis by Xpert MTB/RIF assay with sputum samples between January 1, 2019 and December 31, 2019
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Medical records reviewThe clinical characteristics at the time of diagnosis of rifampin-susceptible pulmonary tuberculosis patients, the Xpert MTB/RIF assay Ct value, the tuberculosis activity score based on AI of the chest image, and treatment results will be collected retrospectively through medical records. | Other | – |
Primary outcome
Negative culture conversion until 8 weeks after initiation of treatment
Time frame: Within 8 weeks of initiating treatment
Conversion from positive tuberculosis culture to negative tuberculosis culture
Time to negative culture conversion
Time frame: Within 6 months of initiating treatment
Time (days) to conversion from positive tuberculosis culture to negative tuberculosis culture
Treatment outcome including 1) Cure 2) Treatment completion 3) Treatment failure 4) Death 5) Loss of follow-up 6) Unknown
Time frame: Within 2 years of initiating treatment
1. Cure: confirmed negative culture conversion plus negative culture results from at least one sputum on the month of treatment completion 2. Treatment completion: confirmed negative culture conversion at least once during treatment 3. Treatment failure: positive culture results after 4 months of treatment 4. Death: death during treatment 5. Loss of follow-up: loss of follow-up during treatment 6. Unknown
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Individual participant dataSharing planned: No. There is no plan to make IPD available.
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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.
Jae-Joon Yim, MD, PhD principal investigator
Seoul National 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 Pulmonary Tuberculoses and Tuberculosis, Pulmonary, run by Jae-Joon Yim 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae-Joon Yim, MD, PhD (+82-2-2072-2059, yimjj@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative culture conversion until 8 weeks after initiation of treatment (time frame: Within 8 weeks of initiating treatment). The study lists 3 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 28 Jul 2022; AzTrials last refreshed its copy on 3 Nov 2026.