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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Tuberculosis, Pulmonary; Pulmonary Tuberculoses
• Intervention / Treatment: Other: Medical records review

• Study Type: Observational
• Enrollment (Anticipated): 900

Contacts and Locations

• Study Contact: Name: Hyung-Jun Kim, MD; Phone Number: +82317877844; Email: dr.hjkim@snubh.org

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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	Within 2 years of initiating treatment

Collaborators and Investigators

• Sponsor: Jae-Joon Yim

Study record dates

Study Major Dates

• Study Start (Anticipated): July 18, 2022
• Primary Completion (Anticipated): July 18, 2023
• Study Completion (Anticipated): July 18, 2023

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Tuberculosis; Tuberculosis, Pulmonary
• Other Study ID Numbers: H-2206-179-1336

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No