NCT03012217

Brief Summary

This is a performance study to test the sensitivity and specificity of the BioFire FilmArray Respiratory Panel (RP) 2. The purpose of this study is to prospectively collect and test residual NPS specimens and generate performance data to support regulatory classification of the FilmArray RP2 as an in vitro diagnostic (IVD) in the US, European Union (EU), Canada, and other regions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,612

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 3, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

Enrollment Period

3 months

First QC Date

January 3, 2017

Last Update Submit

January 10, 2017

Conditions

Upper Resp Tract Infection

Outcome Measures

Primary Outcomes (1)

  • sensitivity and specificity of device

    3 months

Study Arms (1)

Specimens that meet inclusion criteria

Other: Observational Study

Interventions

Observational StudyOTHER
Specimens that meet inclusion criteria

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Only residual NPS specimens from patients with clinician-ordered respiratory pathogen testing will be enrolled.

You may qualify if:

  • Specimen is residual NPS in VTM left over from standard of care testing under clinician order for respiratory pathogen analysis
  • Specimen has been held at appropriate temperature
  • Sufficient volume remaining after standard of care testing and available for use in the study

You may not qualify if:

  • Specimen other than NPS in VTM (e.g. nasopharyngeal aspirate, anterior or midturbinate swab, oropharyngeal swab, NPS collected in medium other than VTM)
  • Specimen cannot be tested within the defined storage parameters
  • Insufficient specimen volume for testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84108, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal swabs.

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Observation

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2017

First Posted

January 6, 2017

Study Start

September 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 12, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(3)