Xofluza-Wearables Feasibility-Study

Launched by CHILDREN'S HOSPITAL OF PHILADELPHIA · Nov 27, 2023

Keywords

ClinConnect Summary

The Xofluza-Wearables Feasibility Study is a clinical trial that aims to find out if using smartwatches to detect influenza early, along with quick testing and treatment with a medication called Baloxavir, leads to better recovery outcomes for certain patients. The study focuses on patients who have received organ transplants or are on the waiting list for a transplant, as well as their household members. By comparing these patients' recovery to national statistics, researchers hope to improve care and outcomes for those infected with influenza.

To participate, individuals must be at least 5 years old and either a transplant recipient, on the transplant waiting list, or a household member of a transplant recipient. They will need to regularly wear a smartwatch and perform at-home tests to check for influenza. If they test positive for influenza, they may receive Baloxavir treatment within 48 hours of showing symptoms. It's important to note that participants must not have any allergies to Baloxavir or certain other health conditions that would prevent them from joining the study. Overall, participants can expect to be closely monitored and contribute to important research that could help improve treatment responses for influenza in vulnerable populations.

Gender

ALL

Eligibility criteria

• • 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.
• • 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 \< 20 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 \< 20 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.