Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02578875 |
| Other study ID # |
160001 |
| Secondary ID |
16-CC-0001 |
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 12, 2015 |
| Est. completion date |
January 1, 2025 |
Study information
| Verified date |
April 11, 2024 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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]).
