Using smart wearables to detect and treat influenza in transplant patients

A Feasibility Study of Xofluza Treatment of Influenza in Pediatric Transplant Recipients, Waitlisted Subjects and Household Members After Early Infection Alerting Using Wearable Devices

This study tests if smartwatches can help find flu early in kids who have had transplants so they can get treatment faster and feel better.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 540 (estimated)
• Ages: 2 Years and up
• Sex: All
• Sponsor: Children's Hospital of Philadelphia (other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT06161454 on ClinicalTrials.gov

What this trial studies

This interventional study aims to evaluate the effectiveness of early influenza detection using smart wearable devices in pediatric transplant recipients. Participants will wear smartwatches that monitor physiological signs to detect influenza before symptoms appear, allowing for timely treatment with Baloxavir Marboxil. The study compares outcomes from this proactive approach against national statistics for similar patient populations. It focuses on improving post-infection outcomes for vulnerable transplant patients through rapid testing and treatment.

Who should consider this trial

Good fit: Ideal candidates include pediatric kidney, heart, liver, or lung transplant recipients aged 5 years and older who are willing to wear a smartwatch and participate in at-home testing.

Not a fit: Patients who are not transplant recipients or those who are not willing to use wearable devices or undergo testing may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the health outcomes of transplant patients by enabling earlier treatment of influenza.

How similar studies have performed: Previous studies have shown promise in using wearable devices for early infection detection, indicating potential success for this novel approach.

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.

Where this trial is running

Philadelphia, Pennsylvania

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Matthew O Connor, MD — Children's Hospital of Philadelphia
• Study coordinator: Brendan Keating, PhD

Conditions: Infection, Coronavirus, Infections, Influenza, Transplant, Infection Viral, Wearable Devices, smart wearable device, Xofluza