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

University of Cape Town (UCT)

Status: Completed

Conditions: Tuberculosis

Treatments: Device: Urine LAM strip test

Study type: Interventional

Funder types: Other

Identifiers

NCT01770730

LAMRCT

Details and patient eligibility

About

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.

Enrollment: 2,618 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,618 participants in 2 patient groups

LAM plus standard care

Experimental group

Description:

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

Treatment:

Device: Urine LAM strip test

Standard care

No Intervention group

Description:

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