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

This study is currently recruiting participants.
Verified January 2013 by University of Cape Town
Sponsor:
Collaborators:
University of Zimbabwe
University of Zambia
NIMR - Mbeya Medical Research Programme
Information provided by (Responsible Party):
Jonathan Peter, University of Cape Town
ClinicalTrials.gov Identifier:
NCT01770730
First received: January 11, 2013
Last updated: January 15, 2013
Last verified: January 2013

January 11, 2013
January 15, 2013
January 2013
April 2014   (final data collection date for primary outcome measure)
All-cause mortality [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
All-cause mortality at 8-weeks after study enrollment
Same as current
Complete list of historical versions of study NCT01770730 on ClinicalTrials.gov Archive Site
  • Change in TB-related morbidity score [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    Comparative change in TB score between baseline and 8 weeks after enrollment
  • Change in Karnofsky performance index [ Time Frame: Baseline and 8 week ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Diagnostic accuracy (sensitivity, specificity, predictive values and likelihood ratios) of the urine LAM strip test using TB culture as the diagnostic reference standard
Same as current
Not Provided
Not Provided
 
A Trial of the Urine LAM Strip Test for TB Diagnosis Amongst Hospitalized HIV-infected Patients
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Tuberculosis
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
  • 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
    Intervention: Device: Urine LAM 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2400
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Jonathan Peter, MD +27214066119 Jonny.Peter@uct.ac.za
Contact: Keertan Dheda, MD PhD +27214067654 Keertan.Dheda@uct.ac.za
South Africa,   Tanzania,   Zambia,   Zimbabwe
 
NCT01770730
LAMRCT
No
Jonathan Peter, University of Cape Town
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
University of Cape Town
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP