Tuberculosis
Conditions
Keywords
urine LAM strip test, diagnostics, tuberculosis
Brief summary
The novel urine LAM point-of-care strip test offers potential clinical utility to improve TB diagnosis in HIV co-infected patients. Urine LAM strip test performance improves with increasing illness severity and more advanced immunosuppression, thus offering the greatest potential utility in hospitalised HIV-infected patients with advanced immunosuppression (CD4 cell count less than 200). However, in the context of high rates of empiric treatment and the availability of other novel TB diagnostics, the clinical impact of the urine LAM strip test is unknown. This study will investigate the impact of the urine LAM strip test. The study hypothesis is that the urine LAM strip test, when combined with standard TB diagnostics (smear microscopy and culture) will significantly improve TB treatment-related outcomes (TB-related mortality, morbidity and length of hospital stay) in HIV-infected hospitalized patients when compared to standard TB diagnostics alone.
Interventions
DEVICEUrine LAM strip test
This is a point-of-care lateral flow strip test to detect the presence of lipoarabinomannan (LAM) in patient urine samples. Only patients with a grade 2-5 visual band intensity will be considered positive and commenced on treatment
Sponsors
University of Zimbabwe
University of Zambia
NIMR - Mbeya Medical Research Programme
University of Cape Town
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV-infected (1x rapid HIV test positive) * Considered TB suspect by attending doctor (must comprise at least 1 of the following: current fever or cough, drenching night sweats, self-reported LOW) * Illness severity sufficient to warrant hospitalization * ≥18 years old * Provision of informed consent
Exclusion criteria
* HIV-uninfected * Patients receiving any anti-TB medication in the 60 days prior to testing * Unable to provide 30mls urine * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 8 weeks | All-cause mortality at 8-weeks after study enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in TB-related morbidity score | Baseline and 8 weeks | Comparative change in TB score between baseline and 8 weeks after enrollment |
| Change in Karnofsky performance index | Baseline and 8 week | Comparative changes in the Karnofsky performance index between baseline and 8 weeks following enrollment |
| Hospital length of stay | Date of hospital discharge (max 8 weeks) minus date of admission | This is the number of days of hospital admission for enrolled patients up to a maximum of 8 weeks post enrollment. |
| Diagnostic accuracy of urine LAM strip test | 8 weeks | Diagnostic accuracy (sensitivity, specificity, predictive values and likelihood ratios) of the urine LAM strip test using TB culture as the diagnostic reference standard |
Countries
South Africa, Tanzania, Zambia, Zimbabwe
Outcome results
None listed