Overview

This trial is active, not recruiting.

Conditions tuberculosis, tuberculosis, pulmonary, tuberculosis, miliary
Treatments alere "determine" lateral-flow urine lipoarabinomannan assay, alere "clearview" elisa urine lam assay
Sponsor Tuberculosis Clinical Diagnostics Research Consortium
Collaborator Makerere University
Start date January 2011
End date February 2012
Trial size 504 participants
Trial identifier NCT01525134, DMID10-0001, NA_00038297

Summary

The purpose of this study is to evaluate the accuracy, diagnostic yield, operational performance, and time to diagnosis of a novel lateral-flow urine lipoarabinomannan (LAM) test in detecting tuberculosis in HIV-infected adults.

A secondary study objective is to determine the accuracy, efficiency, costs, and cost-effectiveness of various combinations of Tuberculosis (TB) diagnostic tests, including the novel Xpert MTB/Rif test.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic

Primary Outcomes

Measure
Sensitivity of the lateral-flow urine LAM assay (LF-LAM)
time frame: One year
Failure rate of the lateral-flow urine LAM assay
time frame: One year
Inter-reader variability of the lateral-flow urine LAM assay
time frame: One year
Specificity of the lateral-flow urine LAM assay (LF-LAM)
time frame: One year

Secondary Outcomes

Measure
Sensitivity of the ELISA-based urine LAM test
time frame: One year
Diagnostic yield (expressed as number of TB cases detected) of various diagnostic strategies (see description)
time frame: One year
Time to diagnosis (expressed in days) of various diagnostic strategies (see description)
time frame: One year
Accuracy, efficiency, costs, and cost-effectiveness of various combinations of TB diagnostic tests
time frame: One year
Satisfaction of lateral-flow urine LAM test operators
time frame: One year
Specificity (Sp) of the ELISA-based urine LAM test
time frame: One year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria (Individuals must meet all of the following inclusion criteria in order to be eligible to participate): - Informed consent - Suspected active tuberculosis - Willingness and ability to comply with study procedures - Any one or more of the following: - Current cough - Fever at any time within the preceding 4 weeks - Night sweats at any time within the preceding 4 weeks - Weight loss within the preceding 4 weeks - HIV-positive based on any one or more of the following: - written results of a positive HIV antibody test, and/or - written results of a positive HIV viral load, and/or - documentation in the medical record of positive HIV status by a treating clinician. Exclusion Criteria (Any subjects meeting any of the following exclusion criteria at baseline will be excluded from study participation): - Multidrug tuberculosis treatment for greater than two days within the previous 60 days - Unwillingness or inability to provide a urine sample - Known chronic pulmonary condition, e.g. asthma, chronic obstructive pulmonary disease, emphysema - Respiratory distress, defined as respiratory rate of >30 or oxygen saturation <90% - Any specific condition that in the judgment of the investigator precludes participation because it could affect a subject's safety.

Additional Information

Official title Feasibility of Using the Inverness Lateral Flow Urine LAM Test for Diagnosis of Tuberculosis in HIV-Positive TB Suspects
Principal investigator Yukari Manabe, MD
Description Background: Tuberculosis (TB) incidence and mortality have increased dramatically as a result of the HIV epidemic. In parts of sub-Saharan Africa, TB is the leading cause of death among HIV-infected patients and approximately 50% of TB patients are HIV co-infected. Early treatment of TB is hindered by the lack of rapid, accurate diagnostic modalities that can be applied in resource-constrained settings. Mycobacterial culture is the laboratory standard for diagnosis of active TB, but it is costly, requires access to specialized laboratories, and takes weeks to provide results. Sputum smear microscopy detects less than half of HIV-infected TB cases in many settings. The Global Plan to Stop TB has prioritized the development of simple, accurate, inexpensive tests for TB case detection in HIV-positive individuals. LAM: As a strategy for rapid TB diagnosis, the detection of Mycobacterium tuberculosis antigens has been explored over several decades. Lipoarabinomannan (LAM), a glycolipid component of the outer cell wall of mycobacteria, is an attractive diagnostic target for several reasons: it is heat-stable; cleared by the kidney; detectable in urine; and as a bacterial product, has the theoretical potential to discriminate active TB from latent TB infection independent of human immune responses. A urine test could facilitate TB diagnosis in patients in whom sputum is uninformative or not obtainable, and lacks the infection-control risks associated with sputum production or blood collection. Urine LAM detection may be amenable to simple, rapid, inexpensive point-of-care platforms. This is a prospective study to evaluate the accuracy, diagnostic yield, operational performance, and time to diagnosis of a novel lateral-flow urine LAM test in detecting tuberculosis in HIV-infected adults. HIV-positive adults suspected to have TB will be enrolled after providing informed consent. Urine will be obtained for testing using the novel lateral flow urine LAM assay and an existing ELISA-based urine LAM assay. Conventional microbiological tests for TB and chest x-rays will also be performed. These tests will be performed on all participants enrolled (target sample size = 500). A secondary study objective is to determine the accuracy, efficiency, costs, and cost-effectiveness of various combinations of TB diagnostic tests, including the novel Xpert MTB/Rif test. The Xpert MTB/Rif test will be performed on a subset of participants (approximately 200 participants out of the total of 500 participants we expect to enroll for the LAM component of the study.)
Trial information was received from ClinicalTrials.gov and was last updated in February 2012.
Information provided to ClinicalTrials.gov by Tuberculosis Clinical Diagnostics Research Consortium.