A Trial of the Urine LAM Strip Test for TB Diagnosis Amongst Hospitalized HIV-infected Patients (LAMRCT)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01770730 |
Recruitment Status :
Completed
First Posted : January 18, 2013
Last Update Posted : June 3, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tuberculosis | Device: Urine LAM strip test | Not Applicable |
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 |

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
|
- All-cause mortality [ Time Frame: 8 weeks ]All-cause mortality at 8-weeks after study enrollment
- Change in TB-related morbidity score [ Time Frame: Baseline and 8 weeks ]Comparative change in TB score between baseline and 8 weeks after enrollment
- 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
- 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.
- 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

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Study Director: | Keertan Dheda, MD | UCT Lung Infection and Immunity Unit |
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 |
Other Study ID Numbers: |
LAMRCT |
First Posted: | January 18, 2013 Key Record Dates |
Last Update Posted: | June 3, 2015 |
Last Verified: | June 2015 |
urine LAM strip test diagnostics tuberculosis |
Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections |
Bacterial Infections Bacterial Infections and Mycoses Infections |