A Trial of the Urine LAM Strip Test for TB Diagnosis Amongst Hospitalized HIV-infected Patients - Full Text View

Purpose

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.

Condition	Intervention
Tuberculosis	Device: Urine LAM strip test


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Tuberculosis Urine and Urination

Genetic and Rare Diseases Information Center resources: Tuberculosis

U.S. FDA Resources

Further study details as provided by University of Cape Town:

Primary Outcome Measures:

All-cause mortality [ Time Frame: 8 weeks ]
All-cause mortality at 8-weeks after study enrollment

Secondary Outcome Measures:

Change in TB-related morbidity score [ Time Frame: Baseline and 8 weeks ]
Comparative change in TB score between baseline and 8 weeks after enrollment
Change in Karnofsky performance index [ Time Frame: Baseline and 8 week ]
Comparative changes in the Karnofsky performance index between baseline and 8 weeks following enrollment
Hospital length of stay [ Time Frame: 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 [ Time Frame: 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


Enrollment:	2618
Study Start Date:	January 2013
Study Completion Date:	January 2015
Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: LAM plus standard care 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 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 Other Name: Determine TB urine LAM Antigen strip test
No Intervention: Standard care Patients allocated to this study arm will receive standard TB diagnostics currently WHO approved and available at the study site

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770730

Locations


South Africa
University of Cape Town
Cape Town, Western Cape, South Africa, 7945
Tanzania
Mbeya Medical Research Programme
Mbeya, Tanzania
Zambia
University Teaching Hospital
Lusaka, Zambia
Zimbabwe
University of Zimbabwe
Harare, Zimbabwe

Sponsors and Collaborators

University of Cape Town

University of Zimbabwe

University of Zambia

NIMR - Mbeya Medical Research Programme

Investigators


Study Director:	Keertan Dheda, MD	UCT Lung Infection and Immunity Unit

More Information

Publications:

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Jonathan Peter, Honorary consultant, Department of Medicine, University of Cape Town
ClinicalTrials.gov Identifier:	NCT01770730 History of Changes
Other Study ID Numbers:	LAMRCT
Study First Received:	January 11, 2013
Last Updated:	June 1, 2015

Keywords provided by University of Cape Town:


urine LAM strip test diagnostics tuberculosis

Additional relevant MeSH terms:


Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections

ClinicalTrials.gov processed this record on May 23, 2017

A Trial of the Urine LAM Strip Test for TB Diagnosis Amongst Hospitalized HIV-infected Patients (LAMRCT)