NCT02049918

Brief Summary

Collect de-identified, residual samples to support a clinical trial. Samples may be prospectively or retrospectively collected. Overall Study Objective Obtain clinical performance data to characterize clinical performance of the Respiratory Viral Panel on the GenMark Sample-to-Answer Platform.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,487

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2013

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

Study Start

First participant enrolled

November 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

December 28, 2015

Status Verified

December 1, 2015

Enrollment Period

2 years

First QC Date

January 23, 2014

Last Update Submit

December 23, 2015

Conditions

Respiratory Viral Illnesses: Influenza A/B, RSV, Adenovirus

Keywords

Respiratory viruses

Outcome Measures

Primary Outcomes (1)

  • Sample collection study only

    This is an IVD Diagnostic study.

    prospective and retrospective sample collection

Eligibility Criteria

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

Children and adults of any age suspected of having respiratory infection.

You may qualify if:

  • Sample from patients exhibiting signs/symptoms of respiratory viral infection
  • All medical standard-of-care testing requested by the submitting clinician is complete and has been reported to the clinician/requestor.

You may not qualify if:

  • Samples that are incorrectly de-identified

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal Swab

MeSH Terms

Conditions

Adenoviridae Infections

Condition Hierarchy (Ancestors)

DNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Wallace Green, PhD

    Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

  • Michelle Fennell, MHA, MT(ASCP)

    Ingalls Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2014

First Posted

January 30, 2014

Study Start

November 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

December 28, 2015

Record last verified: 2015-12

Locations

US(1)