Clinical trial NCT01770730: A Trial of the Urine LAM Strip Test for TB Diagnosis Amongst Hospitalized HIV-infected Patients
Official title: A Randomized Controlled Trial to Evaluate the Impact of Using a Point-of-care Urine LAM Strip Test for TB Diagnosis Amongst Hospitalized HIV-infected Patients in Resource-poor Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Keywords: urine LAM strip test
diagnostics
tuberculosis
Lead sponsor: University of Cape Town
Sponsor class: OTHER
Collaborators: name: University of Zimbabwe
name: University of Zambia
name: NIMR - Mbeya Medical Research Programme
First posted: 2013-01-18
Enrollment: 2618
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: All-cause mortality
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in TB-related morbidity score
timeFrame: Baseline and 8 weeks
measure: Change in Karnofsky performance index
timeFrame: Baseline and 8 week
measure: Hospital length of stay
timeFrame: Date of hospital discharge (max 8 weeks) minus date of admission
measure: Diagnostic accuracy of urine LAM strip test
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: University of Cape Town
state: Western Cape
city: Mbeya
country: Tanzania
facility: Mbeya Medical Research Programme
city: Lusaka
country: Zambia
facility: University Teaching Hospital
city: Harare
country: Zimbabwe
facility: University of Zimbabwe
Study officials:
affiliation: UCT Lung Infection and Immunity Unit
name: Keertan Dheda, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.