NCT01806285

Brief Summary

The purpose of this sample collection study is to prospectively collect respiratory viral clinical samples, conduct standard of care comparator testing and archive the collected residual samples for future testing in order to establish the clinical performance characteristics of the investigational instrument.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
205

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Typical duration for all trials

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

February 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 7, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1.5 years 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

1.2 years

First QC Date

February 26, 2013

Last Update Submit

December 23, 2015

Conditions

Viral Respiratory Infection

Keywords

Respiratory Virus

Outcome Measures

Primary Outcomes (1)

  • Sample collection study only

    prospective sample collection

Study Arms (1)

Patients with Respiratory Symptoms

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 with onset of symptoms and fever within 5 days of sample collection.

You may qualify if:

  • The specimen is a nasopharyngeal swab.
  • The specimen is from a pediatric or adult male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long term care facility.
  • The specimen is from a patient exhibiting clinical signs and symptoms of respiratory tract infection such as fever, sore throat, shortness of breath, bronchitis, bronchiolitis, and pneumonia.

You may not qualify if:

  • The specimen is not a nasopharyngeal swab.
  • The specimen is from an individual who does not exhibit clinical signs and symptoms of respiratory tract infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal swabs

Study Design

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

Study Record Dates

First Submitted

February 26, 2013

First Posted

March 7, 2013

Study Start

February 1, 2013

Primary Completion

May 1, 2014

Study Completion

November 1, 2015

Last Updated

December 28, 2015

Record last verified: 2015-12