Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Zimbabwe | OTHER |
| University of Zambia | OTHER |
| NIMR - Mbeya Medical Research Programme | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAM plus standard care | Experimental | 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 |
|
| Standard care | No Intervention | Patients allocated to this study arm will receive standard TB diagnostics currently WHO approved and available at the study site |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urine LAM strip test | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | All-cause mortality at 8-weeks after study enrollment | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in TB-related morbidity score | Comparative change in TB score between baseline and 8 weeks after enrollment | Baseline and 8 weeks |
| Change in Karnofsky performance index | Comparative changes in the Karnofsky performance index between baseline and 8 weeks following enrollment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Keertan Dheda, MD | UCT Lung Infection and Immunity Unit | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cape Town | Cape Town | Western Cape | 7945 | South Africa | ||
| Mbeya Medical Research Programme |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22362849 | Background | Peter JG, Theron G, van Zyl-Smit R, Haripersad A, Mottay L, Kraus S, Binder A, Meldau R, Hardy A, Dheda K. Diagnostic accuracy of a urine lipoarabinomannan strip-test for TB detection in HIV-infected hospitalised patients. Eur Respir J. 2012 Nov;40(5):1211-20. doi: 10.1183/09031936.00201711. Epub 2012 Feb 23. | |
| 22015305 | Background |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. | 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 | 8 weeks |
| Mbeya |
| Tanzania |
| University Teaching Hospital | Lusaka | Zambia |
| University of Zimbabwe | Harare | Zimbabwe |
| Lawn SD, Kerkhoff AD, Vogt M, Wood R. Diagnostic accuracy of a low-cost, urine antigen, point-of-care screening assay for HIV-associated pulmonary tuberculosis before antiretroviral therapy: a descriptive study. Lancet Infect Dis. 2012 Mar;12(3):201-9. doi: 10.1016/S1473-3099(11)70251-1. Epub 2011 Oct 17. |
| 23099073 | Background | Peter JG, Theron G, Dheda K. Urine antigen test for diagnosis of HIV-associated tuberculosis. Lancet Infect Dis. 2012 Nov;12(11):825; author reply 826-7. doi: 10.1016/S1473-3099(12)70220-7. No abstract available. |
| 26970721 | Derived | Peter JG, Zijenah LS, Chanda D, Clowes P, Lesosky M, Gina P, Mehta N, Calligaro G, Lombard CJ, Kadzirange G, Bandason T, Chansa A, Liusha N, Mangu C, Mtafya B, Msila H, Rachow A, Hoelscher M, Mwaba P, Theron G, Dheda K. Effect on mortality of point-of-care, urine-based lipoarabinomannan testing to guide tuberculosis treatment initiation in HIV-positive hospital inpatients: a pragmatic, parallel-group, multicountry, open-label, randomised controlled trial. Lancet. 2016 Mar 19;387(10024):1187-97. doi: 10.1016/S0140-6736(15)01092-2. Epub 2016 Mar 10. |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |