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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical records review | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Time to negative culture conversion | Time (days) to conversion from positive tuberculosis culture to negative tuberculosis culture | 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 |
| Within 2 years of initiating treatment |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jae-Joon Yim, MD, PhD | Contact | +82-2-2072-2059 | yimjj@snu.ac.kr | |
| Hyung-Jun Kim, MD | Contact | +82317877844 | dr.hjkim@snubh.org |
| Name | Affiliation | Role |
|---|---|---|
| Jae-Joon Yim, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University | Seoul | 03080 | South Korea |
There is no plan to make IPD available.
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| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |