NCT02880384

Brief Summary

Study to compare the number of community-acquired pneumonia (CAP) pathogens detected using current diagnostic tests to the number detected using the BioFire Diagnostics investigational polymerase chain reaction (PCR) platform.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
570

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

1.2 years

First QC Date

August 23, 2016

Last Update Submit

May 24, 2022

Conditions

Community Acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

  • Pathogen Detection

    Compare the number of CAP pathogens detected using current diagnostic bundle to the number detected using the FilmArray LRTI v.2.0 IUO Panel.

    5 Days

Secondary Outcomes (2)

  • Treatment Influence

    5 Days

  • Nasopharyngeal swabs compared to sputum

    5 Days

Study Arms (1)

FilmArray LRTI v.2.0 IUO Panel

EXPERIMENTAL

Patients will provide sputum or sputum equivalent for FilmArray LRTI v.2.0 IUO Panel testing.

Other: FilmArray LRTI v.2.0 IUO Panel

Interventions

FilmArray LRTI v.2.0 IUO PanelOTHER

Patients will provide sputum or sputum equivalent to be probed with FilmArray LRTI v.2.0 IUO Panelpanel.

FilmArray LRTI v.2.0 IUO Panel

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Emergency Department physician diagnosis of CAP requiring hospitalization

You may not qualify if:

  • Inability to obtain sputum or sputum equivalent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Portland Providence Medical Center

Portland, Oregon, 97213, United States

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • David Gilbert, MD

    Providence Health & Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2016

First Posted

August 26, 2016

Study Start

January 1, 2017

Primary Completion

April 1, 2018

Study Completion

December 20, 2020

Last Updated

May 25, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)