Influenza Clinical Trial
Official title:
A Feasibility Study of Xofluza Treatment of Influenza in Pediatric Transplant Recipients, Waitlisted Subjects and Household Members After Early Infection Alerting Using Wearable Devices
The goal of this prospective, interventional, single-center study is to assess whether the early detection of Influenza with smartwatch algorithms and alerting, rapid testing, and subsequent Baloxavir treatment demonstrate better post-infection outcomes versus publicly available- and Centers for Disease Control (CDC)-derived national statistics for equivalent household populations as well as pediatric kidney, heart, liver, lung transplant recipients and waitlisted patients.
Status | Recruiting |
Enrollment | 540 |
Est. completion date | May 31, 2024 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years and older |
Eligibility | Inclusion Criteria Population 1: Potential Baloxavir treatment group (CHOP transplant subjects 5 years & up) - Willing CHOP male or female kidney, heart, liver or lung single or multiple transplant recipients aged 5 years or older as per FDA guidelines. - Willing to regularly wear a smartwatch and take an at-home positive respiratory virus (RV) panel which will include a diagnoses of Influenza A or B. - Have an antigen positive diagnoses of Influenza A or B (a PCR-based positive clinical diagnoses of Influenza A or B may be requested in "alarm positive plus antigen positive but asymptomatic" cases). - Can be included if their treating physician prescribe prophylactic treatment of Baloxavir if the subject has been exposed to Influenza. - If Baloxavir is prescribed the study subject should be treated within 48 hours of symptom onset (regardless of the alarming time). Population 2: Potential Baloxavir treatment group (CHOP waitlisted subjects 5 years & up) - Willing waitlisted CHOP kidney, heart, liver or lung single or multiple transplant recipients aged 5 years or older, which are anticipated to have a transplant in the next 12 months. - All other inclusion criteria listed in 3.3.1. Population 3: Potential Baloxavir treatment group (non-transplanted household members) - Non-transplanted household member of a CHOP transplant recipient or waitlisted patient - Be at least 5 years of age. - Willing to regularly wear a smartwatch and take an at-home positive respiratory virus (RV) panel for diagnoses of Influenza A or B. - Have a Antigen-based positive diagnoses of Influenza A or B Population 4: Non-Baloxavir treatment subjects - CHOP transplant recipients and all other non-transplanted household members who are 2-4 years of age. - Subjects 5 years and up who are Influenza positive but whom do not receive Baloxavir treatment Exclusion Criteria Population 1: - Any allergy to Baloxavir (although they can remain in the study as an influenza case or control without Baloxavir treatment, or if they have been treated with a different medication for influenza) or a recommendation from the study physicians'/transplant pharmacist(s) not to take Baloxavir. - Subjects weighing < 40 kg - If the subject is unable or unwilling to consent. - If the subject is younger than 5 years of age. - If the subject requires mechanical ventilation at time of enrollment. - If the subject is pregnant or breast feeding at the time of early infection alerting. - If the subject is taking a prohibited medication. These include Influenza antiviral drugs with the exception of oseltamivir and baloxavir (such as peramivir, laninamivir, zanamivir, rimantadine, umifenovir or amantadine). - Unwilling or unable to comply with the study requirements. Population 2: All exclusion criteria listed for Population 1 Population 3: - Subjects weighing < 40 kg - A household transplant recipient is not participating in the study - Any allergy to Baloxavir (although they will remain in the study as an influenza case/control without treatment) - A recommendation from the study physicians'/transplant pharmacist not to take Baloxavir - If the subject is unable or unwilling to consent. - If the subject is younger than 5 years of age. - If the subject is pregnant at screening. - If the subject is taking a prohibited medication. These include Influenza antiviral drugs with the exception of oseltamivir and baloxavir (such as peramivir, laninamivir, zanamivir, rimantadine, umifenovir or amantadine). - Unwilling or unable to comply with the study requirements. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Philadelphia | Genentech, Inc. |
United States,
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* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time-to-Clinical-Response | For subjects infected with Influenza investigators will assess Time-to-Clinical-Response in a time frame up to 30 days post Baloxavir treatment in this study vs comparable data available from national control groups. Time to Clinical Response is based on: (a) temperature ranges as measured by (standard of care and/or smartwatch biometric data), oxygen saturation, respiratory status, HR, and hospitalization status; (b) return to healthy baseline data including from biometric data derived from the subjects' smartwatch; (c) time to symptom resolution in a time frame up to 30 days post Baloxavir treatment as assessed from a return to healthy baseline on the daily questionnaires). | 30 days post-Baloxavir treatment | |
Primary | Incidence of complicated hospital stay(s) | Incidence of complicated hospital stay(s) for a time frame up to 30 days post Baloxavir treatment in this study versus comparable data available from the previously described national control groups. A complicated hospital stay is defined as a hospital admission that was either prolonged (greater than 7 days), requiring ICU level of care or death at day 30 as a result of influenza infection. | 30 days post-Baloxavir treatment | |
Secondary | Incidence of Respiratory Tract Infection Progression Following Treatment | Progression to lower respiratory tract infections in a time frame up to 30 days post Baloxavir treatment in this study versus comparable data available from national control groups. | 30 days post-Baloxavir treatment | |
Secondary | Length of hospital Stay Following Treatment | Length of hospital stay in a time frame up to 30 days post Baloxavir treatment in our study versus comparable data available from national control groups. | 30 days post-Baloxavir treatment | |
Secondary | Oxygen requirement Following Treatment | Oxygen requirement in a time frame up to 30 days post Baloxavir treatment in this study versus comparable data available from national control groups. | 30 days post-Baloxavir treatment | |
Secondary | Rate of Respiratory Failure Following Treatment | Rate of respiratory failure in a time frame up to 30 days post Baloxavir treatment in this study versus comparable data available from national control groups. | 30 days post-Baloxavir treatment | |
Secondary | 30-day Mortality Rate Following Treatment | 30-day mortality for post Baloxavir treatment in this study versus comparable data available from national control groups. | 30 days post-Baloxavir treatment |
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