Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06161454
Status:
RECRUITING
Last Update Posted:
2023-12-26
First Post:
2023-11-27
Brief Title:
Xofluza-Wearables Feasibility-Study
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
Influenza infections are a significant concern for the clinical management of transplant recipients a highly vulnerable immunocompromised patient group Early Influenza detection has major benefits for the successful treatment in that crucial early infection time window and allows for more timely mitigation measures to be employed Xofluza Baloxavir Marboxil FDA approved in 2018 for the treatment of acute Influenza has been shown to have improved outcome characteristics versus Tamiflu Oseltamivir as well as compliance a single pill given once versus 10 pills taken over 5 days for Oseltamivir The timing of the influenza diagnoses and intervention greatly impacts the outcomes in both antiviral medications though Smartwatch devices have demonstrated clear utility to detect early infection using physiological signatures such as sub-symptomatic increases in heart rate HR and body temperature Detection of Influenza and severe acute respiratory syndrome coronavirus-2 SARS-CoV-2 have been shown to be robustly detectable several days prior to clinical symptoms onset in large well-powered smartwatch studies
This is a sub-study of the existing Institutional Review Board IRB 20-017872 protocol Early Detection of SARS-CoV-2 other Infections using Wearable Devices in Pediatric Transplant Patients and Household Members This is a prospective interventional single-center study at The Childrens Hospital of Philadelphia comprising kidney heart liver and lung transplant recipients waitlisted patients and their household members Subjects will wear smartwatch devices to monitor biometrics including HR HR variation HRV and proxies of body temperature A smartwatch alert generated from a validated early infection detection algorithm and alerting platform precipitates subjects to use an at-home collection kit for SARS-CoV-2 Influenza AB and respiratory syncytial virus RSV AB which is then sent to a central clinical lab for polymerase chain reaction PCR-based diagnoses If the transplant recipient is positive for Influenza AB the local clinical care team will be informed to determine if Baloxavir andor any other medication is warranted Genentech will make the Baloxavir medication available via the CHOP transplant pharmacist through the recipients regular pharmacy If the non-transplanted household members are positive for Influenza or exposed to Influenza positive infected subjects their treatment will be determined by their own primary-care All CHOP transplant recipients will have their medical records reviewed for relevant covariates and confounders after Baloxavir treatment Study subjects will complete short daily REDCap symptom forms for the pre- peri- and post-infection periods
This is a sub-study of the existing Institutional Review Board IRB 20-017872 protocol Early Detection of SARS-CoV-2 other Infections using Wearable Devices in Pediatric Transplant Patients and Household Members This is a prospective interventional single-center study at The Childrens Hospital of Philadelphia comprising kidney heart liver and lung transplant recipients waitlisted patients and their household members Subjects will wear smartwatch devices to monitor biometrics including HR HR variation HRV and proxies of body temperature A smartwatch alert generated from a validated early infection detection algorithm and alerting platform precipitates subjects to use an at-home collection kit for SARS-CoV-2 Influenza AB and respiratory syncytial virus RSV AB which is then sent to a central clinical lab for polymerase chain reaction PCR-based diagnoses If the transplant recipient is positive for Influenza AB the local clinical care team will be informed to determine if Baloxavir andor any other medication is warranted Genentech will make the Baloxavir medication available via the CHOP transplant pharmacist through the recipients regular pharmacy If the non-transplanted household members are positive for Influenza or exposed to Influenza positive infected subjects their treatment will be determined by their own primary-care All CHOP transplant recipients will have their medical records reviewed for relevant covariates and confounders after Baloxavir treatment Study subjects will complete short daily REDCap symptom forms for the pre- peri- and post-infection periods
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None