TB-LAM in the Diagnosis of TB

October 20, 2020 updated by: Jun Chen, Shanghai Public Health Clinical Center

Clinical Utility of TB-LAM in the Diagnosis of Active TB in Hospitalized HIV-infected Patients

Tuberculosis (TB) is still the leading cause of death in HIV-infected patients. Early diagnosis of TB substantially improves the survival of HIV-infected patients. Urine based detection of lipoarabinomannan (LAM) provides promising methods for quick diagnosis of TB in HIV-infected patients. However, the sensitivity and specificity of TB-LAM is still not well established, especially in area where non-tuberculosis mycobacterium is also prevalence. Here we aimed to evaluate the clinical utility of TB-LAM in diagnosis of active TB in hospitalized HIV-infected patients.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

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

Description

Inclusion Criteria:

  • Hospitalized HIV-infected patients.
  • Willing to participate into the study.

Exclusion Criteria:

  • Already diagnosed with active TB
  • Received any anti-tuberculosis drugs and/or quinolone for more than 7 days.

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnosis arm
Urine TB-LAM, sputum smear, Gene Xpert, mycobacterial culture
Subjects also undergo clinical evaluation including CT, sputum smear, Gene Xpert and mycobacterial culture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity against microbiological reference standard
Time Frame: 2 months
Number of TB-LAM positive/Number of positive by culture or Gene Xpert
2 months
Specificity against microbiological reference standard
Time Frame: 2 months
1-Number of TB-LAM negative/Number of negative by culture or Gene Xpert or smear
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity against composite reference standard
Time Frame: 2 months
Number of TB-LAM positive/Number of active TB diagnosed clinically
2 months
Specificity against composite reference standard
Time Frame: 2 months
1-Number of TB-LAM negative/Number of TB excluded
2 months

Collaborators and Investigators

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

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)

October 1, 2020

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

October 20, 2020

First Submitted That Met QC Criteria

October 20, 2020

First Posted (Actual)

October 23, 2020

Study Record Updates

Last Update Posted (Actual)

October 23, 2020

Last Update Submitted That Met QC Criteria

October 20, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participant data without individual identification can be provided upon request.

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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