Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle (pCHIMES)

July 13, 2021 updated by: Helen Chu, University of Washington

Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle (pCHIMES)

This study will evaluate a home-based approach to influenza infection control, using prepositioned home-based influenza self-test kits, telemedicine services, and rapid delivery of Xofluza (Baloxavir marboxil) for administration within 48 hours of symptom onset.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Households represent an important location for transmission of influenza. Rapid delivery of Xofluza may reduce household exposures to influenza among susceptible individuals.This study is a pilot study of a home-based approach to influenza infection control, utilizing self-test kits and rapid home delivery of an antiviral. Households with at least 3 individuals residing there at least 4 days a week, including at least 2 household members that are eligible to take antiviral, will be monitored throughout the influenza season for the onset of a cough or two or more acute respiratory infection symptoms. This study will be conducted in households in the Seattle, WA area for one influenza season, beginning November 1, 2019 and ending April 1, 2020. Household will self-monitor for onset of symptoms throughout the influenza season. When symptoms develop, the participant will self-test for influenza infection using a prepositioned home-testing kit. If negative, the ill participant will provide one self-collected nasal swab specimen. If positive, the ill participant will connect with a healthcare provider via the tele-health app on their smartphone to confirm the influenza diagnosis. Next, if eligible to receive Xofluza, the influenza-positive individual will receive a rapid home delivery of Xofluza within 2-6 hours of the positive test result. All influenza-positive participants will provide a self-collected nasal swab specimen at Study Day 0, Study Day 2-3, and Study Day 5-7. For all illness episodes, the ill individual will complete a questionnaire regarding symptom duration and severity, as well as behavioral changes due to illness.

Study Type

Interventional

Enrollment (Actual)

481

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Household Level:
  • Group of at least 3 individuals of any ages defined as at least 3 persons residing at the same address for at least 4 days per calendar week
  • Household group utilizes common household areas
  • At least 2 household members meeting all individual inclusion/exclusion criteria listed below and willing to participate (e.g. at least two members of the household are 12 years of age or older)
  • At least one member of the household has a smartphone
  • Individual Level: Drug Eligible
  • Resident of a household with 3 or more members (including eligible cases) for 4 or more days a calendar week
  • Age 12 years or older weighing at least 40 kg (greater than 88 pounds)
  • Willing and able to take study medication
  • Willing to comply with all study procedures
  • English-speaking
  • Able to provide written, informed consent and/or assent (if applicable)
  • Permanent mailing address that is available for study staff to mail necessary materials
  • Individual Level: Drug Ineligible
  • Resident of a household with 3 or more members (including eligible cases) for 4 or more days a calendar week
  • Willing to comply with all study procedures
  • English-speaking
  • Able to provide written, informed consent and/or assent (if applicable)

Exclusion Criteria:

  • Household Level:
  • Previous documentation of an influenza infection prior to or during the annual influenza season in any household member prior to enrollment
  • Individual Level:
  • Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration
  • Individuals with hypersensitivity to baloxavir
  • Individuals that already have a tele-health account
  • Any individual that has one or more of the following conditions:
  • Pregnant
  • Currently lactating
  • Immunosuppressed or immunocompromised (by disease or medication)
  • Cancer
  • Liver disease
  • Kidney disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Study Drug Eligible
Baloxavir given in 40 mg and 80 mg tablets for single-dose oral consumption during the first influenza infection for that participant
Drug: Baloxavir Marboxil
Individuals willing and able, will receive a weight-based oral dose of baloxavir within 48 hours of symptom onset
Other Names:
  • Xofluza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initiate Antiviral Therapy Within 48 Hours of Symptom Onset
Time Frame: Up to 48 hours
Among symptomatic participants, this outcome measure will be calculated by determining the number of home influenza test-positive, drug eligible participants that were prescribed and rapidly delivered baloxavir by the study within 48 hours of symptom onset.
Up to 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Home Influenza Tests Confirmed by Laboratory Testing
Time Frame: Up to 48 hours
Proportion of individuals who test positive for influenza using the home-based influenza test compared to the number of individuals that test positive for influenza via a PCR laboratory test
Up to 48 hours
Delivered Antivirals Within 48 Hours of Symptom Onset
Time Frame: Up to 48 hours
Proportion of individuals who are delivered antivirals within 48 hours of symptom onset. Only drug eligible study participants prescribed an antiviral
Up to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2019

Primary Completion (ACTUAL)

April 1, 2020

Study Completion (ACTUAL)

April 1, 2020

Study Registration Dates

First Submitted

October 23, 2019

First Submitted That Met QC Criteria

October 24, 2019

First Posted (ACTUAL)

October 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 5, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00008200

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not currently expect to share specimens with outside investigators, but if compelling opportunities arise that will advance the overall objectives of this research, the Executive Committee of the study will consider such requests. They alone have the authority to make such decisions.

All biospecimens (nasal swabs) will be coded and identifiable through the study's main database. Any specimens shared with external investigators (if deemed appropriate by the Executive Committee) will have identifiers removed prior to sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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