Evaluation of a LAM FLISA for the Diagnosis of Tuberculosis (LAM FLISA)

October 5, 2016 updated by: Christian Herzmann, Research Center Borstel

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Borstel, Germany, 23845
        • Research Center Borstel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with confirmed or suspected tuberculosis. Patients with NTM infection or bronchial carcinoma serve as control

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Confirmed tuberculosis
Confirmed non-tuberculous mycobacterial infection
Confirmed bronchial carcinoma
Suspected tuberculosis but confirmed alternative diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of patients with false positive and false negative urine LAM detection
Time Frame: On admission to hospital
On admission to hospital

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of patients with false negative and false positive blood LAM detection
Time Frame: On admission to hospital
On admission to hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

April 23, 2012

First Submitted That Met QC Criteria

April 26, 2012

First Posted (Estimate)

April 30, 2012

Study Record Updates

Last Update Posted (Estimate)

October 6, 2016

Last Update Submitted That Met QC Criteria

October 5, 2016

Last Verified

October 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tuberculosis

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