Evaluation of MiSeq for Microbial Identification in Specimens

NCT02578875 | Completed

• 2 other identifiers: 16000116-CC-0001
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Blood Stream Infections

Keywords

Sequence Technique; Infectious Disease; Pathogen Detection; Diagnostic; Natural History

Outcome Measures

Primary Outcomes (1)

• 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

  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

  At study completion

Study Arms (1)

Sample

Discarded patient samples and autopsy material

Eligibility Criteria

• Age: 2 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinical Center patients@@@@@@

You may qualify if:

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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Communicable Diseases; Disease

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adrian M Zelazny, Ph.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 19, 2015
• Study Start: November 12, 2015
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

US (1)