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Xofluza-Wearables Feasibility-Study

NCT06161454 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 498

Last updated 2025-07-11

No results posted yet for this study

Summary

The goal of this prospective, interventional, single-center study is to assess whether the early detection of Influenza with smart wearable device 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.

Conditions

Interventions

DRUG

Baloxavir Marboxil

Baloxavir marboxil will be administered as either a tablet or granules. Dose is based on body weight: 40 mg for a participants weighing 20-79 kg, or 80 mg for a patient weighing more than or equal to 80 kg

Sponsors & Collaborators

Principal Investigators

  • Matthew O Connor, MD · Children's Hospital of Philadelphia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-14
Primary Completion
2025-04-30
Completion
2025-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06161454 on ClinicalTrials.gov