Perspectives on Antibiotics and Tracking Symptoms in Children (PATSy)

September 17, 2025 updated by: Murdoch Childrens Research Institute

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a mainly observational study looking at the feasibility and acceptability of the study instruments and procedures to be incorporated into an upcoming clinical trial. Parents/guardians will be asked to provide feedback on study procedures and questionnaires. The study will also assess feasibility and acceptability of a shorter course of antibiotic therapy (i.e. stopping earlier) to be tested in the upcoming clinical trial (noting that no antibiotics will be stopped early in this study).

The study will also include a clinical trial component. A small number of participants will be invited to wear a Garmin Smartwatch to collect data about heart rate, heart rate variability, skin temperature and sleep and activity levels. Data collected with the Garmin Smartwatch will be compared to parent reported symptoms (collected via the questionnaires noted above) in order to determine the level of agreement.

All study surveys and Garmin data will be collected through 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.

Study participants will be children (4-17 years of age) who present to the RCH with uncomplicated bacterial infections and are prescribed oral antibiotics (either immediately or as switch from IV antibiotics after transfer to HITH) as standard of care, to assess their and their parents' satisfaction with the study instruments employed in this study, in preparation for the upcoming clinical trial.

WeGuide and Garmin are supporting the PATSy study through the WeGuide and Garmin Health Grant for Digital Health and Wellbeing. The grant includes use of the WeGuide platform and the Garmin Trackers. WeGuide and Garmin have no role in recruitment, data collection, data analysis or publication of the study.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3052

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

- Parent/guardian does not speak English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).
Device: Garmin Smartwatch
Garmin Venu 3 - Worn for the duration of antibiotic course

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of days Garmin Tracker was worn during antibiotic course
Time Frame: Baseline through to Day 10
Participants will wear the Garmin Tracker for the duration of their antibiotic course. Number of days Garmin Tracker worn collected via WeGuide app. 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.
Baseline through to Day 10
Number of parents/participants who report issues (via study-specific questionnaire) with Garmin Tracker use
Time Frame: Day 10
As reported in the daily symptom questionnaires completed by parent/guardian via WeGuide.
Day 10
Number of parents/participants who report issues (via study-specific questionnaire) with Garmin Tracker use
Time Frame: Day 14
As reported in the day 14 follow-up questionnaire completed by parent/guardian via WeGuide.
Day 14
Issues with Garmin Tracker use (as recorded on study-specific questionnaires) - reports by frequency
Time Frame: Day 14
As reported in the day 14 follow-up questionnaire or the daily symptom questionnaires completed by parent/guardian via WeGuide.
Day 14
Acceptability of the Garmin Tracker as measured by a study-specific targeted questionnaire
Time Frame: Day 14
As reported in the day 14 follow-up questionnaire completed by parent/guardian via WeGuide.
Day 14
Percentage of completed study-specific questionnaires
Time Frame: Baseline through to Day 28
All study specific questionnaires completed by parent/guardian via WeGuide
Baseline through to Day 28
Number of parents/participants who report issues completing study-specific questionnaires
Time Frame: Day 10
As reported in the daily symptom questionnaires completed by parent/guardian via WeGuide.
Day 10
Number of parents/participants who report issues completing study-specific questionnaires
Time Frame: Day 28
As reported in the follow-up questionnaire completed by parent/guardian via WeGuide.
Day 28
Issues with completing questionnaires (as recorded on study-specific questionnaires) - reports by frequency
Time Frame: Day 10
As reported in the daily symptom questionnaires completed by parent/guardian via WeGuide.
Day 10
Issues with completing questionnaires (as recorded on study-specific questionnaires) - reports by frequency
Time Frame: Day 28
As reported in the follow-up questionnaires completed by parent/guardian via WeGuide.
Day 28
Number of parents/participants who expressed no concerns with study procedures
Time Frame: Day 28
As reported in questionnaires completed by parent/guardian via WeGuide.
Day 28
Acceptability of the study procedures as measured by a study-specific targeted questionnaire
Time Frame: Day 28
Targeted questions will be asked to the parent/guardian to elicit feedback on study experience. Open-ended questions analysed via thematic analysis, closed-ended questions assessed as a percentage of each response.
Day 28
Number of parents willing to be contacted regarding joining a parent group
Time Frame: Day 28
Parents will be asked if they are willing to be contacted regarding participation in an upcoming parent group. The parent group will helps us understand parent/child points of view in antibiotic research and provide consumer input into the development of the upcoming clinical trial.
Day 28
Number of parents/participants who completed all study-specific procedures
Time Frame: Day 28
All study-specific procedures completed by parent/guardian via WeGuide - includes questionnaires and Garmin Tracker use (for those participants that are invited to and consent to wearing)
Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement between reports of fever recorded by the Garmin Tracker versus the daily questionnaire - measured using Cohen's kappa coefficient
Time Frame: Baseline to Day 10
As assessed by Garmin Tracker and study-specific daily questionnaires completed by parent/guardian via WeGuide
Baseline to Day 10
Agreement between reports of sleep quality recorded by the Garmin Tracker versus the daily questionnaire - measured using Cohen's kappa coefficient
Time Frame: Baseline to Day 10
As assessed by Garmin Tracker and in study-specific daily questionnaires completed by parent/guardian via WeGuide
Baseline to Day 10
Agreement between reports for activity level recorded by the Garmin Tracker versus reports of daytime lethargy/tiredness in the daily questionnaire
Time Frame: Baseline to Day 10
As assessed by Garmin Tracker and in study specific daily questionnaires completed by parent/guardian via WeGuide
Baseline to Day 10
Number of participants who re-start antibiotics within 28 days of antibiotic commencement as reported in study-specific questionnaire
Time Frame: Day 28
As reported in the study-specific day 28 follow-up questionnaire completed by parent/guardian via WeGuide.
Day 28
Number of participants who are still unwell at Day 28 as reported in study-specific questionnaire
Time Frame: Day 28
As reported in the study-specific day 28 follow-up questionnaire completed by parent/guardian via WeGuide.
Day 28
Number of participants who finished complete course of antibiotics as reported in study-specific questionnaire
Time Frame: Day 14
As reported in the study-specific day 14 follow-up questionnaire completed by parent/guardian via WeGuide. Participant who finished complete course of antibiotics is defined as a participant whose parent reports that all prescribed doses are administered exactly as prescribed in the study specific questionnaire delivered via WeGuide
Day 14
Number of reported doses of antibiotics administered versus doses prescribed as reported in study-specific questionnaire
Time Frame: Day 10
As reported in study-specific daily questionnaires completed by parent/guardian via WeGuide
Day 10
Number of participants who report stopping antibiotics early due to resolution of symptoms - as reported on the study-specific questionnaire
Time Frame: Day 14
Stopping antibiotics early as reported in day 14 follow-up questionnaire completed by parent/guardian via WeGuide. Symptom resolution defined as normalisation of Garmin Tracker health parameters or parent/guardian reporting of no symptoms in daily symptom questionnaire completed via WeGuide.
Day 14
Reason for stopping antibiotics early as reported on study-specific questionnaire
Time Frame: Day 14
As reported in the study-specific day 14 follow-up questionnaire completed by parent/guardian via WeGuide.
Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Murdoch Childrens Research Institute

Collaborators

Royal Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

July 10, 2025

First Submitted That Met QC Criteria

July 22, 2025

First Posted (Actual)

July 30, 2025

Study Record Updates

Last Update Posted (Actual)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 17, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 116407

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results that are published after de-identification (text, tables, figures and appendices) will be made available long-term for use by future researchers from a recognised research institution who meet access criteria as outlined below.

IPD Sharing Time Frame

12 months following analysis and publication of the subsequent planned clinical trial.

IPD Sharing Access Criteria

Researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions for access.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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