HIV Infections, Non-Tuberculous Mycobacterial Pneumonia, Tuberculosis
Conditions
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.
Interventions
DIAGNOSTIC_TESTAlere TB-LAM
Subjects also undergo clinical evaluation including CT, sputum smear, Gene Xpert and mycobacterial culture.
Sponsors
Shanghai Public Health Clinical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity against microbiological reference standard | 2 months | Number of TB-LAM positive/Number of positive by culture or Gene Xpert |
| Specificity against microbiological reference standard | 2 months | 1-Number of TB-LAM negative/Number of negative by culture or Gene Xpert or smear |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactJun Chen, M.D
Outcome results
None listed