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

Not Applicable

Completed

• Conditions: Tuberculosis
• Interventions: Device: Urine LAM strip test

• Registration Number: NCT01770730
• Lead Sponsor: University of Cape Town

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-11
• Study First Submitted QC: 2013-01-15
• Study First Posted: 2013-01-18
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-01
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2618

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LAM plus standard care	Urine LAM strip test	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

Primary Outcome Measures

Name	Time	Method
All-cause mortality	8 weeks	All-cause mortality at 8-weeks after study enrollment

Secondary Outcome Measures

Name	Time	Method
Change in Karnofsky performance index	Baseline and 8 week	Comparative changes in the Karnofsky performance index between baseline and 8 weeks following enrollment
Hospital length of stay	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	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
Change in TB-related morbidity score	Baseline and 8 weeks	Comparative change in TB score between baseline and 8 weeks after enrollment

Trial Locations

Locations (4)

Mbeya Medical Research Programme; 🇹🇿 Mbeya, Tanzania

University of Zimbabwe; 🇿🇼 Harare, Zimbabwe

University Teaching Hospital; 🇿🇲 Lusaka, Zambia

University of Cape Town; 🇿🇦 Cape Town, Western Cape, South Africa