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Completed

NCT Number: NCT01770730

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cape Town, Cape Town, Western Cape, South Africa

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Determine TB urine LAM Antigen strip test

Primary outcomes

  1. All-cause mortality

    Time frame: 8 weeks

    All-cause mortality at 8-weeks after study enrollment

Secondary outcomes

  1. Change in TB-related morbidity score

    Time frame: Baseline and 8 weeks

    Comparative change in TB score between baseline and 8 weeks after enrollment

  2. 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

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

University of Cape Town

Other

Collaborators

  • NIMR - Mbeya Medical Research Programme
  • University of Zambia
  • University of Zimbabwe

Registry information

Official study 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

Acronym: LAMRCT

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jan 18, 2013
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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