Tuberculosis Clinical Trial
— LAM FLISAOfficial title:
Diagnostic Evaluation of a Urine and Plasma Based LAM FLISA for the Diagnosis of Infection With Mycobacterium Tuberculosis
Tuberculosis is a bacterial infection causing 1.1 million deaths annually worldwide.
Diagnosis of the disease is often time consuming or challenging. Many cases of tuberculosis
require advanced and expensive diagnostic methods that restrict their availability in
resource limited countries where the burden of tuberculosis is highest. The development of
rapid point of care diagnostics is required.
Lipoarabinomannan (LAM) is part of the bacterial cell wall in M. tuberculosis. It is
released when bacteria are multiplying or dying. LAM can be detected in the urine since it
is filtered from the blood in the kidneys. The detection of LAM in the urine by conventional
enzyme linked immuno-sorbent assay (ELISA) techniques was hampered in the past by a low
sensitivity and multiple processing steps. Recently, fluorescence linked immuno-sorbent
assay (FLISA) has been shown to detect LAM in concentrations that are several magnitudes
lower that with ELISA based methods. Furthermore the procedure requires less separate steps
for processing the sample.
This study aims to validate the new diagnostic test by comparing patients with (a) confirmed
tuberculosis (n=25), (b) infection with non-tuberculous mycobacteria (n=25), (c) bronchial
carcinoma (n=25), (d) suspected tuberculosis but confirmed alternative diagnosis (estimated
n=20). Single blood and urine samples of these groups will be used to evaluate the
sensitivity and specificity of the test.
In patients with confirmed tuberculosis the LAM FLISA will also be assessed as a biomarker
for the monitoring of tuberculosis treatment success. Initially, 2-5 samples blood and urine
are required during the first week, followed by twice weekly and weekly sampling intervals
over a period of 12 weeks maximum. The study participation ends when the patient is
discharged from hospital.
As a substudy, the blood samples will be used to evaluate an enzyme linked immuno-sorbent
assay (ELISA) for the detection of lipid antigens that are specific for Mycobacterium
tuberculosis.
Status | Completed |
Enrollment | 92 |
Est. completion date | February 2013 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Suspected or confirmed infection with M. tuberculosis (MTB) or confirmed infection with non-tuberculous mycobacteria (NTM) or confirmed bronchial carcinoma 2. Oral and written consent to study participation (children: parent's consent) Exclusion Criteria: 1. Inability to follow the study requirements 2. Patient in custodianship or guardianship |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | Research Center Borstel | Borstel |
Lead Sponsor | Collaborator |
---|---|
Research Center Borstel | German Cancer Research Center |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of patients with false positive and false negative urine LAM detection | On admission to hospital | No | |
Secondary | Rate of patients with false negative and false positive blood LAM detection | On admission to hospital | No |
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