A Retrospective Cohort Study to Develop Markers for TB Severity and Treatment Progress

Tuberculosis, Pulmonary Clinical Trial

Official title:

A Retrospective Cohort Study to Develop Markers for TB Severity and Treatment Progress

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05477966
• Other study ID #: H-2206-179-1336
• Status: Not yet recruiting
• Start date: July 18, 2022
• Est. completion date: July 18, 2023

Study information

• Verified date: July 2022
• Source: Seoul National University Hospital
• Contact: Jae-Joon Yim, MD, PhD
• Phone: +82-2-2072-2059
• Email: yimjj[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 900
• Est. completion date: July 18, 2023
• Est. primary completion date: July 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with rifampin-susceptible pulmonary tuberculosis by Xpert MTB/RIF assay with sputum samples between January 1, 2019 and December 31, 2019

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Pulmonary Tuberculoses
• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Other:
• Medical records review
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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Jae-Joon Yim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative culture conversion until 8 weeks after initiation of treatment	Conversion from positive tuberculosis culture to negative tuberculosis culture	Within 8 weeks of initiating treatment
Primary	Time to negative culture conversion	Time (days) to conversion from positive tuberculosis culture to negative tuberculosis culture	Within 6 months of initiating treatment
Primary	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	Within 2 years of initiating treatment