PATSy Perspectives on Antibiotics and Tracking Symptoms in Children - a Mixed Methods Feasibility Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The study will assess families' perspectives and decision-making regarding the duration of oral antibiotic courses prescribed to children (4-17 years) who present with uncomplicated bacterial infections at the Royal Children's Hospital (RCH) Emergency Department (ED). The study will involve (i) children discharged from ED on oral antibiotics and (ii) children transferred to Hospital-in-the-Home (HITH) on IV antibiotics who then switch to oral antibiotics. In addition, the study will assess how feasible and acceptable it is to track children's symptoms via the Garmin Smartwatch and the WeGuide platform (WeGuide is a patient engagement software platform that allows for enrolment, consent, and data collection \[via questionnaires/surveys and from the Garmin Smartwatches\] through a singular platform).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 17
Healthy Volunteers: f
View:

• Between the ages of ≥ 4 years and ≤ 17 years at enrolment.

• Diagnosed with any of the following at RCH ED: urinary tract infection (UTI), cellulitis, impetigo, pharyngitis, tonsillitis, respiratory tract infections, otitis media.

• Prescribed oral antibiotics (either immediately or as switch from IV antibiotics after transfer to HITH) as standard of care due to having uncomplicated infection as deemed by their treating doctor.

• Parent/guardian provides a signed and dated informed consent form.

Locations
Other Locations
Australia
Royal Children's Hospital
RECRUITING
Melbourne
Contact Information
Primary
A/Prof Penelope Bryant
penelope.bryant@rch.org.au
+61383416200
Backup
Lucy Hill
lucy.hill@mcri.edu.au
+61383416200
Time Frame
Start Date: 2025-09-16
Estimated Completion Date: 2026-08
Participants
Target number of participants: 300
Treatments
Experimental: Intervention arm
All participants eligible participants parent/guardian will be asked to complete:~1. Daily symptom tracking questionnaires for the duration of their antibiotic course~2. One-time questionnaire (at enrolment) about parents/guardians' perspectives on antibiotic course duration and stopping antibiotics early~3. Two short follow up questionnaires (day 14 and day 28) to record if antibiotics have been restarted and for perspectives/concerns and feedback on study instruments and procedures.~In addition, a small number of participants will also be asked to wear a Garmin Smartwatch for the duration of their antibiotic course (3 devices only available, will be offered when available - approximately 60 participants).
Sponsors
Collaborators: Royal Children's Hospital
Leads: Murdoch Childrens Research Institute

This content was sourced from clinicaltrials.gov