- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04600232
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
Status
Unknown
Intervention / Treatment
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- TB-LAM
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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