TB-LAM in the Diagnosis of TB

Shanghai Public Health Clinical Center

Status: Unknown

Conditions: Non-Tuberculous Mycobacterial Pneumonia; Tuberculosis; HIV Infections

Treatments: Diagnostic Test: Alere TB-LAM

Study type: Interventional

Funder types: Other

Identifiers

NCT04600232

TB-LAM

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

Diagnosis arm

Experimental group

Description:

Urine TB-LAM, sputum smear, Gene Xpert, mycobacterial culture

Treatment:

Diagnostic Test: Alere TB-LAM