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

NCT05477966 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 900

Last updated 2022-07-28

No results posted yet for this study

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).

Conditions

  • Pulmonary Tuberculoses
  • Tuberculosis, Pulmonary

Interventions

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.

Sponsors & Collaborators

  • Jae-Joon Yim

    lead OTHER

Principal Investigators

  • Jae-Joon Yim, MD, PhD · Seoul National University Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-18
Primary Completion
2023-07-18
Completion
2023-07-18

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05477966 on ClinicalTrials.gov