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

July 26, 2022 updated by: Jae-Joon Yim
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

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative culture conversion until 8 weeks after initiation of treatment
Time Frame: Within 8 weeks of initiating treatment
Conversion from positive tuberculosis culture to negative tuberculosis culture
Within 8 weeks of initiating treatment
Time to negative culture conversion
Time Frame: Within 6 months of initiating treatment
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
Time Frame: 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
Within 2 years of initiating treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jae-Joon Yim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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