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A Multi-Site Clinical Evaluation of the ARIES Bordetella Assay in Symptomatic Patients

NCT02862262 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1052

Last updated 2018-10-04

No results posted yet for this study

Summary

A three-arm, multi-site clinical evaluation of the ARIES Bordetella Assay for the detection and identification of Bordetella pertussis (B. pertussis) and Bordetella parapertussis (B. parapertussis) nucleic acids in prospectively collected, de-identified, left-over clinical specimens; banked, pre-selected clinical specimens; and contrived specimens.

Conditions

  • Bordetella Infections
  • Bordetella Pertussis Infection
  • Bordetella Parapertussis Infection

Interventions

DEVICE

ARIES Bordetella Assay

Sponsors & Collaborators

  • Luminex Molecular Diagnostics

    lead INDUSTRY

Principal Investigators

  • Ronald Dunn · Luminex Molecular Diagnostics

  • Timothy S Uphoff, PhD · Marshfield Labs

  • Stephen Young, PhD · Tricore Reference Lab

  • Ryan Relich, PhD · IU Health Pathology Laboratory

  • Ted E Schutzbank, PhD · St. John Hospital & Medical Center

  • Amy L Leber, PhD · Nationwide Children's Hospital Laboratory

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2016-11-30
Completion
2016-11-14
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02862262 on ClinicalTrials.gov