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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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 Intervention
Tuberculosis
Device: Urine LAM strip test

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Cape Town:

Primary Outcome Measures:
  • All-cause mortality [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    All-cause mortality at 8-weeks after study enrollment


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 2400
Study Start Date: January 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770730

Contacts
Contact: Jonathan Peter, MD +27214066119 Jonny.Peter@uct.ac.za
Contact: Keertan Dheda, MD PhD +27214067654 Keertan.Dheda@uct.ac.za

Locations
South Africa
University of Cape Town Recruiting
Cape Town, Western Cape, South Africa, 7945
Contact: Jonathan Peter, MD    +27214066119    Jonny.Peter@uct.ac.za   
Principal Investigator: Jonathan Peter, MD         
Sub-Investigator: Keertan Dheda, MD         
Sub-Investigator: Grant Theron, PhD         
Tanzania
Mbeya Medical Research Programme Recruiting
Mbeya, Tanzania
Contact: Petra Clowes, MD    +255252503364    pclowes@mmrp.org   
Principal Investigator: Michael Hoelscher, MD         
Sub-Investigator: Andrea Rachow, MD         
Sub-Investigator: Petra Clowes, MD         
Zambia
University Teaching Hospital Not yet recruiting
Lusaka, Zambia
Contact: Duncan Chanda, MD    +260964100097    duncanchanda@gmail.com   
Principal Investigator: Duncan Chanda, MD         
Sub-Investigator: Peter Mwaba, MD         
Zimbabwe
University of Zimbabwe Not yet recruiting
Harare, Zimbabwe
Contact: Lynn Zijenah, PhD    +2634791631    lzijenah@gmail.com   
Principal Investigator: Lynn Zijenah, PhD         
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

Additional Information:
Publications:
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
Study First Received: January 11, 2013
Last Updated: January 15, 2013
Health Authority: South Africa: Human Research Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on September 18, 2014