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

This study has been completed.
University of Zimbabwe
University of Zambia
NIMR - Mbeya Medical Research Programme
Information provided by (Responsible Party):
Jonathan Peter, University of Cape Town Identifier:
First received: January 11, 2013
Last updated: June 1, 2015
Last verified: June 2015
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
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:

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


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

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
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Please refer to this study by its identifier: NCT01770730

South Africa
University of Cape Town
Cape Town, Western Cape, South Africa, 7945
Mbeya Medical Research Programme
Mbeya, Tanzania
University Teaching Hospital
Lusaka, Zambia
University of Zimbabwe
Harare, Zimbabwe
Sponsors and Collaborators
University of Cape Town
University of Zimbabwe
University of Zambia
NIMR - Mbeya Medical Research Programme
Study Director: Keertan Dheda, MD UCT Lung Infection and Immunity Unit
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jonathan Peter, Honorary consultant, Department of Medicine, University of Cape Town 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

Additional relevant MeSH terms:
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections processed this record on May 22, 2017