Back to results

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

Primary Purpose

Influenza, Respiratory Viral Infection

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Baloxavir Marboxil

About this trial

This is an interventional treatment trial for Influenza focused on measuring influenza, flu, antiviral, baloxavir, Xofluza, rapid delivery, self-test

Eligibility Criteria

3 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Washington

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Study Drug Eligible

Arm Description

Baloxavir given in 40 mg and 80 mg tablets for single-dose oral consumption during the first influenza infection for that participant

Outcomes

Primary Outcome Measures

Initiate Antiviral Therapy Within 48 Hours of Symptom Onset

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.

Secondary Outcome Measures

Home Influenza Tests Confirmed by Laboratory Testing

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

Delivered Antivirals Within 48 Hours of Symptom Onset

Proportion of individuals who are delivered antivirals within 48 hours of symptom onset. Only drug eligible study participants prescribed an antiviral

Full Information

NCT ID

NCT04141930

First Posted

October 23, 2019

Last Updated

July 13, 2021

Sponsor

University of Washington

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04141930

Brief Title

Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle

Acronym

pCHIMES

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

November 1, 2019 (Actual)

Primary Completion Date

April 1, 2020 (Actual)

Study Completion Date

April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

Collaborators

Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza, Respiratory Viral Infection

Keywords

influenza, flu, antiviral, baloxavir, Xofluza, rapid delivery, self-test

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

481 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study Drug Eligible

Arm Type

Other

Arm Description

Baloxavir given in 40 mg and 80 mg tablets for single-dose oral consumption during the first influenza infection for that participant

Intervention Type

Drug

Intervention Name(s)

Baloxavir Marboxil

Other Intervention Name(s)

Xofluza

Intervention Description

Individuals willing and able, will receive a weight-based oral dose of baloxavir within 48 hours of symptom onset

Primary Outcome Measure Information:

Title

Initiate Antiviral Therapy Within 48 Hours of Symptom Onset

Description

Time Frame

Up to 48 hours

Secondary Outcome Measure Information:

Title

Home Influenza Tests Confirmed by Laboratory Testing

Description

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

Time Frame

Up to 48 hours

Title

Delivered Antivirals Within 48 Hours of Symptom Onset

Description

Proportion of individuals who are delivered antivirals within 48 hours of symptom onset. Only drug eligible study participants prescribed an antiviral

Time Frame

Up to 48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Helen Y Chu, MD, MPH

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Washington

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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.

Citations:

PubMed Identifier

30184455

Citation

Hayden FG, Sugaya N, Hirotsu N, Lee N, de Jong MD, Hurt AC, Ishida T, Sekino H, Yamada K, Portsmouth S, Kawaguchi K, Shishido T, Arai M, Tsuchiya K, Uehara T, Watanabe A; Baloxavir Marboxil Investigators Group. Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents. N Engl J Med. 2018 Sep 6;379(10):913-923. doi: 10.1056/NEJMoa1716197.

Results Reference

background

PubMed Identifier

14745701

Citation

Hayden FG, Belshe R, Villanueva C, Lanno R, Hughes C, Small I, Dutkowski R, Ward P, Carr J. Management of influenza in households: a prospective, randomized comparison of oseltamivir treatment with or without postexposure prophylaxis. J Infect Dis. 2004 Feb 1;189(3):440-9. doi: 10.1086/381128. Epub 2004 Jan 26.

Results Reference

background

PubMed Identifier

11176912

Citation

Welliver R, Monto AS, Carewicz O, Schatteman E, Hassman M, Hedrick J, Jackson HC, Huson L, Ward P, Oxford JS; Oseltamivir Post Exposure Prophylaxis Investigator Group. Effectiveness of oseltamivir in preventing influenza in household contacts: a randomized controlled trial. JAMA. 2001 Feb 14;285(6):748-54. doi: 10.1001/jama.285.6.748.

Results Reference

background

PubMed Identifier

20561390

Citation

Leung YH, Li MP, Chuang SK. A school outbreak of pandemic (H1N1) 2009 infection: assessment of secondary household transmission and the protective role of oseltamivir. Epidemiol Infect. 2011 Jan;139(1):41-4. doi: 10.1017/S0950268810001445. Epub 2010 Jun 21.

Results Reference

background

PubMed Identifier

24268590

Citation

Fry AM, Goswami D, Nahar K, Sharmin AT, Rahman M, Gubareva L, Azim T, Bresee J, Luby SP, Brooks WA. Efficacy of oseltamivir treatment started within 5 days of symptom onset to reduce influenza illness duration and virus shedding in an urban setting in Bangladesh: a randomised placebo-controlled trial. Lancet Infect Dis. 2014 Feb;14(2):109-18. doi: 10.1016/S1473-3099(13)70267-6. Epub 2013 Nov 22.

Results Reference

background

PubMed Identifier

31436527

Citation

Takashita E, Ichikawa M, Morita H, Ogawa R, Fujisaki S, Shirakura M, Miura H, Nakamura K, Kishida N, Kuwahara T, Sugawara H, Sato A, Akimoto M, Mitamura K, Abe T, Yamazaki M, Watanabe S, Hasegawa H, Odagiri T. Human-to-Human Transmission of Influenza A(H3N2) Virus with Reduced Susceptibility to Baloxavir, Japan, February 2019. Emerg Infect Dis. 2019 Nov;25(11):2108-2111. doi: 10.3201/eid2511.190757. Epub 2019 Nov 17.

Results Reference

background

Learn more about this trial

Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle

We'll reach out to this number within 24 hrs