NCT04600232

TB-LAM in the Diagnosis of TB

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Shanghai Public Health Clinical Center · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections
• Tuberculosis
• Non-Tuberculous Mycobacterial Pneumonia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Alere TB-LAM	Subjects also undergo clinical evaluation including CT, sputum smear, Gene Xpert and mycobacterial culture.

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-01-01
• Completion: 2021-02-01
• First posted: 2020-10-23
• Last updated: 2020-10-23