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

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ClinicalTrials.gov Identifier: NCT01770730
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : June 3, 2015
Sponsor:
Collaborators:
University of Zimbabwe
University of Zambia
NIMR - Mbeya Medical Research Programme
Information provided by (Responsible Party):
Jonathan Peter, University of Cape Town

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tuberculosis Device: Urine LAM strip test Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2618 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official 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
Study Start Date : January 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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
 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
No Intervention: Standard care
Patients allocated to this study arm will receive standard TB diagnostics currently WHO approved and available at the study site


Outcome Measures
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Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: 8 weeks ]
    All-cause mortality at 8-weeks after study enrollment


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01770730


Locations
South Africa
University of Cape Town
Cape Town, Western Cape, South Africa, 7945
Tanzania
Mbeya Medical Research Programme
Mbeya, Tanzania
Zambia
University Teaching Hospital
Lusaka, Zambia
Zimbabwe
University of Zimbabwe
Harare, Zimbabwe
Sponsors and Collaborators
University of Cape Town
University of Zimbabwe
University of Zambia
NIMR - Mbeya Medical Research Programme
Investigators
Study Director: Keertan Dheda, MD UCT Lung Infection and Immunity Unit
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jonathan Peter, Honorary consultant, Department of Medicine, University of Cape Town
ClinicalTrials.gov Identifier: NCT01770730     History of Changes
Other Study ID Numbers: LAMRCT
First Posted: January 18, 2013    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015

Keywords provided by Jonathan Peter, University of Cape Town:
urine LAM strip test
diagnostics
tuberculosis

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections