Evaluation of MiSeq for Microbial Identification in Specimens

Background:

Researchers are testing a new way to find out what causes infections in people in hospitals.

Current techniques use chemical or biological tests on a person s samples. Samples are blood, tissue, stool, saliva, urine, etc. Researchers are testing new techniques that use a device called MiSeq. It can sequence all of the DNA (genetic material) in a sample. This may show microorganisms, such as bacteria, fungi, and viruses that cause infection. Researchers want to know if the new test works as well or better than current tests. They will do this by looking at about 250 samples.

Objective:

To test if MiSeq works as well as or better than current tests to identify microorganisms that cause infection.

Eligibility:

NIH patients whose samples have been sent to the Microbiology Service s lab for routine microbiologic testing.

Design:

Participants will consent to have samples they gave as part of their routine medical care used in the study. For those under age 18, a parent or legal guardian will consent.

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Key information

Conditions

Blood Stream Infections Communicable Diseases Disease Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

2 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

About this study

The purpose of this study is to evaluate and optimize testing that uses a next-generation DNA sequencing instrument, Illumina MiSeq, along with the associated computer infrastructure and bioinformatics software required for sequence analysis. This system is ultimately intended for use by the NIH Clinical Center Department of Laboratory Medicine to identify infectious agents in primary patient specimens. Next generation sequencing techniques based on sequencing of total DNA from primary specimens are expected to have many advantages over classical microbiological approaches. These include the detection of pathogens directly from primary specimens that may be difficult or impossible to culture.

In this study, discarded patient samples and autopsy material will be tested with the MiSeq system to identify and classify bacteria, viruses, and other pathogens. For the purpose of this study, the term samples will refer to any sample such as swabs, tissue biopsies, blood, feces, saliva, urine, wound, etc. The investigators analyzing the sequencing results will be blinded to the microbiology culture results for a validation subset of specimens to be tested with the MiSeq system. The results of the MiSeq analysis will be converted into a form that can be compared with the Microbiology Services official culture results that are stored in the laboratory information system (software from SCC SOFT Computer [Clearwater, FL, USA]).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

INCLUSION CRITERIA

Discarded specimens will be used for this study.
Patients from whom the specimens are derived are required to be consented.

Treatment and study plan

Primary outcomes

Evaluate and optimize testing that uses a next-generation DNA sequencing instrument, Illumina MiSeq, along with the associated computer infrastructure and bioinformatics software required to sequence analysis

Time frame: At study completion

Evaluate and optimize testing that uses a next generation DNA sequencing instrument, Illumina MiSeq, along with the associated computer infrastructure and bioinformatics software required to sequence analysis

Sponsors and collaborators

Lead sponsor

National Institutes of Health Clinical Center (CC)

Nih

Registry information

Important dates

Study start: 2015
Primary completion: 2019
Study completion: 2019
First posted: Oct 19, 2015
Registry last updated: Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed