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

Tuberculosis Clinical Trial

— LAMRCT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01770730
• Other study ID #: LAMRCT
• Status: Completed
• Phase: N/A
• First received: January 11, 2013
• Last updated: June 1, 2015
• Start date: January 2013
• Est. completion date: January 2015

Study information

• Verified date: June 2015
• Source: University of Cape Town
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2618
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Tuberculosis

Intervention

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

Locations

Country	Name	City	State
South Africa	University of Cape Town	Cape Town	Western Cape
Tanzania	Mbeya Medical Research Programme	Mbeya
Zambia	University Teaching Hospital	Lusaka
Zimbabwe	University of Zimbabwe	Harare

Sponsors (4)

Lead Sponsor	Collaborator
University of Cape Town	NIMR - Mbeya Medical Research Programme, University of Zambia, University of Zimbabwe

Countries where clinical trial is conducted

South Africa,  Tanzania,  Zambia,  Zimbabwe, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	All-cause mortality at 8-weeks after study enrollment	8 weeks	No
Secondary	Change in TB-related morbidity score	Comparative change in TB score between baseline and 8 weeks after enrollment	Baseline and 8 weeks	No
Secondary	Change in Karnofsky performance index	Comparative changes in the Karnofsky performance index between baseline and 8 weeks following enrollment	Baseline and 8 week	No
Secondary	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	No
Secondary	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	No

External Links

•   UCT Lung Infection and Immunity website