An interventional study of Urine LAM strip test in Tuberculosis, sponsored by University of Cape Town. Completed at 4 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-03.
Sponsored by University of Cape Town · Not applicable, Interventional, and Diagnostic
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.
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's enrollment of 2,618 is above the median of 150 across 952 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →University of Cape Town is the lead sponsor of 109 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Patients allocated to this study arm will receive urine LAM strip testing in addition to the standard TB diagnostic tools WHO approved and available at each site
Device: Urine LAM strip test
Patients allocated to this study arm will receive standard TB diagnostics currently WHO approved and available at the study site
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
Also known as: Determine TB urine LAM Antigen strip test
All-cause mortality
All-cause mortality at 8-weeks after study enrollment
Time frame: 8 weeks
Change in TB-related morbidity score
Comparative change in TB score between baseline and 8 weeks after enrollment
Time frame: Baseline and 8 weeks
Change in Karnofsky performance index
Comparative changes in the Karnofsky performance index between baseline and 8 weeks following enrollment
Time frame: Baseline and 8 week
Hospital length of stay
This is the number of days of hospital admission for enrolled patients up to a maximum of 8 weeks post enrollment.
Time frame: Date of hospital discharge (max 8 weeks) minus date of admission
Diagnostic accuracy of urine LAM strip test
Diagnostic accuracy (sensitivity, specificity, predictive values and likelihood ratios) of the urine LAM strip test using TB culture as the diagnostic reference standard
Time frame: 8 weeks
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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University of Cape Town