NCT01947049

Brief Summary

The purpose of this study is to:

  1. 1.Evaluate the clinical performance of a newly available highly-sensitive rapid influenza test, Xpert Flu.
  2. 2.Derive and validate an adult clinical decision guideline to guide clinical testing of influenza patients who meed CDC criteria for antiviral treatment.
  3. 3.Evaluate impact of rapid influenza testing for antiviral treatment.
  4. 4.Determine cost effectiveness of influenza testing and treatment strategies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,011

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

4 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

July 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2014

Completed
Last Updated

September 18, 2017

Status Verified

September 1, 2017

Enrollment Period

12 months

First QC Date

September 17, 2013

Last Update Submit

September 15, 2017

Conditions

Influenza

Keywords

Influenzadiagnostic testingantiviral treatmentrapid influenza testing

Outcome Measures

Primary Outcomes (1)

  • Clinical performance of Xpert Flu

    The primary outcome is the sensitivity and specificity of Cepheid Xpert Flu in detecting Influenza, as well as the positive and negative predictive value.

    one year

Secondary Outcomes (3)

  • Clinical decision guideline

    one year

  • Clinical Utility of Xpert Flu

    one year

  • Cost-effectiveness

    one year

Study Arms (2)

Control Arm

NO INTERVENTION

Participants in this arm will receive usual care (influenza testing and treatment)

Rapid Testing

EXPERIMENTAL

Participants in this arm will receive rapid influenza testing with Xpert Flu.

Other: Rapid Influenza Testing with Xpert Flu

Interventions

Rapid Influenza Testing with Xpert FluOTHER

Participants with recieve rapid influenza testing with Xpert Flu

Rapid Testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old or older
  • Acute respiratory tract infection, i.e. in the past two days the subject has experienced any of the following symptoms: new or increased cough, new or increased shortness of breath, change in sputum production (for adults 65 years or older), new sinus pain, new nasal congestion/rhinorrhea, new sore throat, new fever, triage temperature greater than or equal to 38F
  • CDC Criteria for influenza antiviral treatment, i.e. is the subject at risk for influenza complications or does the subject have potential current influenza complications including: 65 years old or older, pregnant (or less than 2 weeks post-partum), American Indian or Alaska Native, morbid obesity (BMI greater than 40), current resident of a chronic care facility, chronic pulmonary disease, cardiovascular disease (except isolated hypertension), renal disease, hepatic disease, hematologic disease, metabolic disease, neurologic disease, immunosupression due to \[HIV or AIDS, transplant, chemotherapy, medications, other - specify\]. OR does the subject have potential current influenza complications such as: admitted to the hospital or a diagnosis of pneumonia.

You may not qualify if:

  • Unable to speak or understand English or Spanish
  • Unable to provide consent
  • Lack of follow up information (i.e. working telephone number)
  • Have an influenza diagnosis in the past 2 weeks (i.e. either given antivirals or had a confirmatory influenza test)
  • Previously enrolled in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Maricopa Medical Center

Phoenix, Arizona, 85008, United States

Location

Olive View - UCLA Medical Center

Sylmar, California, 91342, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Truman Medical Center

Kansas City, Missouri, 64108, United States

Location

Related Publications (1)

  • Dugas AF, Hsieh YH, LoVecchio F, Moran GJ, Steele MT, Talan DA, Rothman RE; Emergency Department National Influenza Network Investigators. Derivation and Validation of a Clinical Decision Guideline for Influenza Testing in 4 US Emergency Departments. Clin Infect Dis. 2020 Jan 1;70(1):49-58. doi: 10.1093/cid/ciz171.

    PMID: 30843056DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Andrea Dugas, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

  • Richard Rothman, MD, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 17, 2013

First Posted

September 20, 2013

Study Start

July 1, 2013

Primary Completion

June 30, 2014

Study Completion

June 30, 2014

Last Updated

September 18, 2017

Record last verified: 2017-09

Locations

US(4)