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NCT04600232 Clinical Trial

TB-LAM in the Diagnosis of TB

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04600232
Other study ID # TB-LAM
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2020
Est. completion date February 2021

Study information
Verified date October 2020
Source Shanghai Public Health Clinical Center
Contact Jun Chen, M.D
Phone +86-21-37990333
Email qtchenjun@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 400
Est. completion date February 2021
Est. primary completion date January 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Alere TB-LAM
Subjects also undergo clinical evaluation including CT, sputum smear, Gene Xpert and mycobacterial culture.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Public Health Clinical Center

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity against microbiological reference standard Number of TB-LAM positive/Number of positive by culture or Gene Xpert 2 months
Primary Specificity against microbiological reference standard 1-Number of TB-LAM negative/Number of negative by culture or Gene Xpert or smear 2 months
Secondary Sensitivity against composite reference standard Number of TB-LAM positive/Number of active TB diagnosed clinically 2 months
Secondary Specificity against composite reference standard 1-Number of TB-LAM negative/Number of TB excluded 2 months
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