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

• Conditions: Pulmonary Tuberculoses; Tuberculosis, Pulmonary

• Registration Number: NCT05477966
• Lead Sponsor: Jae-Joon Yim

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-07
• Study Start: 2022-07-18
• Study First Submitted: 2022-07-18
• Study First Submitted QC: 2022-07-26
• Last Update Submitted: 2022-07-26
• Study First Posted: 2022-07-28
• Last Update Posted: 2022-07-28
• Primary Completion: 2023-07-18
• Study Completion: 2023-07-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 900

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Negative culture conversion until 8 weeks after initiation of treatment	Within 8 weeks of initiating treatment	Conversion from positive tuberculosis culture to negative tuberculosis culture
Time to negative culture conversion	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	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

Trial Locations

Locations (1)

Seoul National University; 🇰🇷 Seoul, Korea, Republic of