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NCT06161454 · ClinicalTrials.gov registry record · Phase 4
Xofluza-Wearables Feasibility-Study
A Phase 4 study of Influenza and Infections, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- Phase 4
- Development phase
- 498
- Enrollment target
- 1
- Study location
NCT06161454: Completed Phase 4 study of Influenza and Infections, sponsored by Children's Hospital of Philadelphia.
NCT06161454 is a Phase 4 study of Influenza and Infections that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 498 participants, below the 36,801-participant average among 156 other Influenza trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06161454, a Phase 4 study of Influenza and Infections, has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 498 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Baloxavir Marboxil
Study Locations (1)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 498 participants |
| Start Date | 2023-12-14 |
| Est. Completion | 2025-04-30 |
| Phase | Phase 4 |
What the finished NCT06161454 record still lists
NCT06161454 is an interventional study that assigns participants to a tested intervention. The registered 498 participants enrollment target is mid-sized for trials with a published cap, below the 36,801-participant average among 156 other Influenza trials with a reported enrollment target (99% lower).
The record links to 5 conditions, with Influenza appearing as the primary indexed condition, and to 1 intervention - of which Baloxavir Marboxil is the first listed.
NCT06161454 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06161454 about?
NCT06161454 is a clinical study titled "Xofluza-Wearables Feasibility-Study". 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 Cent...
What is the current status of trial NCT06161454?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 498 participants. The study started on 2023-12-14. Estimated completion is 2025-04-30.
What conditions does trial NCT06161454 study?
This clinical trial studies the following conditions: Influenza, Infections, Transplant, Infection Viral, Infection, Coronavirus.
What interventions are being tested in trial NCT06161454?
The interventions under investigation include: Baloxavir Marboxil (DRUG).
Who is sponsoring clinical trial NCT06161454?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06161454 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06161454's enrollment target sits among peer trials
498 52nd of 156 higher than 105 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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