Pulmonary Tuberculoses, Tuberculosis, Pulmonary
Conditions
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).
Interventions
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
Jae-Joon Yim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Contacts
Primary ContactJae-Joon Yim, MD, PhD
Backup ContactHyung-Jun Kim, MD
Outcome results
None listed