Clinical trial NCT04141930: Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle
Official title: Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle (pCHIMES)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Respiratory Viral Infection
Keywords: influenza
flu
antiviral
baloxavir
Xofluza
rapid delivery
self-test
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2019-10-28
Enrollment: 481
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Initiate Antiviral Therapy Within 48 Hours of Symptom Onset
timeFrame: Up to 48 hours
Secondary outcomes:
measure: Home Influenza Tests Confirmed by Laboratory Testing
timeFrame: Up to 48 hours
measure: Delivered Antivirals Within 48 Hours of Symptom Onset
timeFrame: Up to 48 hours
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Helen Y Chu, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.