Evaluation of a LAM FLISA for the Diagnosis of Tuberculosis

Tuberculosis Clinical Trial

— LAM FLISA  

Official title:

Diagnostic Evaluation of a Urine and Plasma Based LAM FLISA for the Diagnosis of Infection With Mycobacterium Tuberculosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01587677
• Other study ID #: RCBorstel001
• Status: Completed
• Phase: N/A
• First received: April 23, 2012
• Last updated: October 5, 2016
• Start date: February 2012
• Est. completion date: February 2013

Study information

• Verified date: October 2016
• Source: Research Center Borstel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Tuberculosis

Locations

Country	Name	City	State
Germany	Research Center Borstel	Borstel

Sponsors (2)

Lead Sponsor	Collaborator
Research Center Borstel	German Cancer Research Center

Country where clinical trial is conducted

Germany, 

Outcome

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