TB-LAM in the Diagnosis of TB
- Conditions
- HIV InfectionsTuberculosisNon-Tuberculous Mycobacterial Pneumonia
- Interventions
- Diagnostic Test: Alere TB-LAM
- Registration Number
- NCT04600232
- Lead Sponsor
- Shanghai Public Health Clinical Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
- Hospitalized HIV-infected patients.
- Willing to participate into the study.
- Already diagnosed with active TB
- Received any anti-tuberculosis drugs and/or quinolone for more than 7 days.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Diagnosis arm Alere TB-LAM Urine TB-LAM, sputum smear, Gene Xpert, mycobacterial culture
- Primary Outcome Measures
Name Time Method Specificity against microbiological reference standard 2 months 1-Number of TB-LAM negative/Number of negative by culture or Gene Xpert or smear
Sensitivity against microbiological reference standard 2 months Number of TB-LAM positive/Number of positive by culture or Gene Xpert
- Secondary Outcome Measures
Name Time Method Sensitivity against composite reference standard 2 months Number of TB-LAM positive/Number of active TB diagnosed clinically
Specificity against composite reference standard 2 months 1-Number of TB-LAM negative/Number of TB excluded