Status:
UNKNOWN
Feasibility of a Lateral Flow Urine Lipoarabinomannan (LAM) Test for Diagnosis of Tuberculosis
Lead Sponsor:
Tuberculosis Clinical Diagnostics Research Consortium
Collaborating Sponsors:
Makerere University
Conditions:
Tuberculosis
Tuberculosis, Pulmonary
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 tubercul...
Detailed 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 p...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
504 Patients enrolled
Trial Details
Trial ID
NCT01525134
Start Date
January 1 2011
End Date
April 1 2012
Last Update
February 2 2012
Active Locations (2)
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1
Infectious Diseases Institute, Makerere University
Kampala, Uganda
2
Mulago National Referral Hospital
Kampala, Uganda