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

NCT01770730 | Completed

• 1 other identifier: LAMRCT
• Study Type: interventional
• Target: 2,618
• Locations: 3 countries
• Sites: 3

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.

Conditions

Tuberculosis

Keywords

urine LAM strip test; diagnostics; tuberculosis

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  All-cause mortality at 8-weeks after study enrollment

  8 weeks

Secondary Outcomes (4)

• Change in TB-related morbidity score

  Baseline and 8 weeks

• Change in Karnofsky performance index

  Baseline and 8 week

• Hospital length of stay

  Date of hospital discharge (max 8 weeks) minus date of admission

• Diagnostic accuracy of urine LAM strip test

  8 weeks

Study Arms (2)

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

Device: Urine LAM strip test

Standard care

NO INTERVENTION

Patients allocated to this study arm will receive standard TB diagnostics currently WHO approved and available at the study site

Interventions

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

Also known as: Determine TB urine LAM Antigen strip test

LAM plus standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cape Town: lead
• University of Zimbabwe: collaborator
• University of Zambia: collaborator
• NIMR - Mbeya Medical Research Programme: collaborator

Study Sites (4)

University of Cape Town

Cape Town, Western Cape, 7945, South Africa

Location

Mbeya Medical Research Programme

Mbeya, Tanzania

Location

University Teaching Hospital

Lusaka, Zambia

Location

University of Zimbabwe

Harare, Zimbabwe

Location

Related Publications (4)

• 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.

  PMID: 22362849 BACKGROUND

• 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.

  PMID: 22015305 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.

  PMID: 23099073 BACKGROUND

• 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.

  PMID: 26970721 DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Keertan Dheda, MD

  UCT Lung Infection and Immunity Unit

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Honorary consultant, Department of Medicine

Study Record Dates

• First Submitted: January 11, 2013
• First Posted: January 18, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: June 3, 2015

Record last verified: 2015-06

Locations

ZI (1); ZA (1); TA (1)