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

• Sponsor: Jae-Joon Yim (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05477966
• Collaborator: (none)
• Enrollment: 900
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 75.1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Tuberculoses; Tuberculosis, Pulmonary	Other: Medical records review

Study Design

• Study Type: Observational
• Anticipated Enrollment: 900 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: A Retrospective Cohort Study to Develop Markers for TB Severity and Treatment Progress
• Anticipated Study Start Date: Jul 18, 2022
• Anticipated Primary Completion Date: Jul 18, 2023
• Anticipated Study Completion Date: Jul 18, 2023

Outcome Measures

Primary Outcome Measures

1. 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

2. Time to negative culture conversion [Within 6 months of initiating treatment]

   Time (days) to conversion from positive tuberculosis culture to negative tuberculosis culture

3. 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]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University	Seoul		Korea, Republic of	03080

Sponsors and Collaborators

• Jae-Joon Yim

Investigators

• Principal Investigator: Jae-Joon Yim, MD, PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jae-Joon Yim, Principal Investigator, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT05477966
• Other Study ID Numbers: H-2206-179-1336
• First Posted: Jul 28, 2022
• Last Update Posted: Jul 28, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Tuberculosis; Tuberculosis, Pulmonary

Study Results

No Results Posted as of Jul 28, 2022