Influenza Clinical Trial
— pCHIMESOfficial title:
Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle (pCHIMES)
Verified date | July 2021 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | Genentech, Inc. |
United States,
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
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 |
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