NCT00863343

Brief Summary

The primary objective of this study is to evaluate the performance of the MSD® Influenza Test in detecting influenza A and influenza B in subjects presenting with influenza-like-illness (ILI).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
391

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2010

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
terminated

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

March 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2009

Completed
12 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

March 1, 2012

Completed
Last Updated

March 1, 2012

Status Verified

January 1, 2012

Enrollment Period

4 months

First QC Date

March 16, 2009

Results QC Date

August 5, 2011

Last Update Submit

January 30, 2012

Conditions

Influenza Human

Keywords

Influenza infectionsOrthomyxoviridae infections

Outcome Measures

Primary Outcomes (4)

  • MSD Influenza A Test Results Against Cell Culture

    A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared.

    1 day

  • MSD Influenza B Test Results Against Cell Culture

    A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.

    1 day

  • MSD Influenza A Test Results Against Culture and PCR

    A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.

    1 day

  • MSD Influenza B Test Results Against Culture and PCR

    A nasal sample is tested on the MSD Influenza Test, which provides a positive or negative result. A separate nasal swab is tested by tissue cell culture, which provides a positive or negative result. These two results are then compared, and PCR is performed on discrepant results and used to reconcile differences.

    1 day

Study Arms (1)

All

Anyone presenting with influenza-like-illness

Biological: Public Health Notification

Interventions

Public Health NotificationBIOLOGICAL

For any H5 positive results, notification of the result to the site's local public health authorities.

All

Eligibility Criteria

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

Individuals visiting a primary care site.

You may qualify if:

  • Any subject (all ages) presenting with ILI (defined as fever \[subjective or documented\] and cough or sore throat), and suspected of having influenza.
  • Subject (parent, guardian, or authorized legal representative) gives informed consent or assent (child) to the study, and provides signed authorization for use and disclosure of protected health information.

You may not qualify if:

  • Any subject classified as "high risk" for exposure to avian or novel influenza, as determined by a Risk-Assessment Questionnaire.
  • Subjects who had prior nasal wash/aspirate or nasopharyngeal wash/aspirate specimens collected for routine health-care purposes within the same suspected influenza infection episode.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Naval Health Research Center

San Diego, California, 92106, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

John T Mather Hospital

Port Jefferson, New York, 11777, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Viral transport media containing nasal swab extract.

MeSH Terms

Conditions

Influenza, HumanOrthomyxoviridae Infections

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Dennis Mertz, Director Regulatory and Clinical Affairs
Organization
Meso Scale Diagnostics, LLC.
dmertz@mesoscale.com
240 631-2522

Study Officials

  • Jacqueline Perodin, PhD, CCRP

    Meso Scale Diagnostics

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

March 16, 2009

First Posted

March 18, 2009

Study Start

March 1, 2010

Primary Completion

July 1, 2010

Study Completion

August 1, 2010

Last Updated

March 1, 2012

Results First Posted

March 1, 2012

Record last verified: 2012-01

Locations

US(3)