MedTrace Logo

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

NCT01770730 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2618

Last updated 2015-06-03

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University of Zimbabwe

    collaborator OTHER

  • University of Zambia

    collaborator OTHER

  • NIMR - Mbeya Medical Research Programme

    collaborator UNKNOWN

  • University of Cape Town

    lead OTHER

Principal Investigators

  • Keertan Dheda, MD · UCT Lung Infection and Immunity Unit

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-12-31
Completion
2015-01-31

Countries

  • South Africa
  • Tanzania
  • Zambia
  • Zimbabwe

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01770730 on ClinicalTrials.gov