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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01770730
Other study ID # LAMRCT
Secondary ID
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


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
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