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

NCT05477966 | Unknown

• 1 other identifier: H-2206-179-1336
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

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).

Conditions

Pulmonary Tuberculoses; Tuberculosis, Pulmonary

Outcome Measures

Primary Outcomes (3)

• 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

  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

  Within 2 years of initiating treatment

Interventions

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients diagnosed with rifampin-susceptible pulmonary tuberculosis by Xpert MTB/RIF assay with sputum samples between January 1, 2019 and December 31, 2019

You may not qualify if:

• None

Sponsors & Collaborators

• Jae-Joon Yim: lead

Study Sites (1)

Seoul National University

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jae-Joon Yim, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jae-Joon Yim, MD, PhD

CONTACT

+82-2-2072-2059; yimjj@snu.ac.kr

Hyung-Jun Kim, MD

CONTACT

+82317877844; dr.hjkim@snubh.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 28, 2022
• Study Start: July 18, 2022
• Primary Completion: July 18, 2023
• Study Completion: July 18, 2023
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)