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

Influenza Clinical Trial

— pCHIMES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04141930
• Other study ID #: STUDY00008200
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: July 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 481
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• Respiratory Viral Infection
• Virus Diseases

Intervention

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

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. Epub 2004 Jan 26. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 48 hours
Secondary	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	Up to 48 hours
Secondary	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	Up to 48 hours