Urinary Tract InfectionPATSyNCT07093749
Perspectives on Antibiotics and Tracking Symptoms in Children
A study testing Garmin Smartwatch in people with Urinary Tract Infection and Cellulitis, run by Murdoch Childrens Research Institute at 1 site in Australia.
Trial 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). Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Urinary Tract Infection, Cellulitis, Impetigo
- What is being tested?
- Garmin Smartwatch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteAustralia
- Study dates
- 16 Sep 2025to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Parent/guardian does not speak English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Royal Children's Hospital
Melbourne, Victoria, 3052
A/Prof Penelope Bryant, +61393455522, penelope.bryant@rch.org.au
Lucy Hill, lucy.hill@mcri.edu.au
About this study
Official title: 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).
Read the 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.
- Conditions
- Urinary Tract Infection, Cellulitis, Impetigo, Pharyngitis, Tonsillitis, Respiratory Tract Infections
- Being tested
- Garmin Smartwatch
- Keywords
- Paediatrics, Antibiotics, Digital Health, Infection
- Medical subject headings
- Urinary Tract Infections, Cellulitis, Impetigo, Pharyngitis, Tonsillitis, Respiratory Tract Infections, Otitis Media, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garmin SmartwatchDevice
Garmin Venu 3 - Worn for the duration of antibiotic course
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | 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). Receives: Device: Garmin Smartwatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of days Garmin Tracker was worn during antibiotic course
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.
Measured: Baseline through to Day 10
Number of parents/participants who report issues (via study-specific questionnaire) with Garmin Tracker use
As reported in the daily symptom questionnaires completed by parent/guardian via WeGuide.
Measured: Day 10
Number of parents/participants who report issues (via study-specific questionnaire) with Garmin Tracker use
As reported in the day 14 follow-up questionnaire completed by parent/guardian via WeGuide.
Measured: Day 14
Issues with Garmin Tracker use (as recorded on study-specific questionnaires) - reports by frequency
As reported in the day 14 follow-up questionnaire or the daily symptom questionnaires completed by parent/guardian via WeGuide.
Measured: Day 14
Acceptability of the Garmin Tracker as measured by a study-specific targeted questionnaire
As reported in the day 14 follow-up questionnaire completed by parent/guardian via WeGuide.
Measured: Day 14
Percentage of completed study-specific questionnaires
All study specific questionnaires completed by parent/guardian via WeGuide
Measured: Baseline through to Day 28
Number of parents/participants who report issues completing study-specific questionnaires
As reported in the daily symptom questionnaires completed by parent/guardian via WeGuide.
Measured: Day 10
Number of parents/participants who report issues completing study-specific questionnaires
As reported in the follow-up questionnaire completed by parent/guardian via WeGuide.
Measured: Day 28
Issues with completing questionnaires (as recorded on study-specific questionnaires) - reports by frequency
As reported in the daily symptom questionnaires completed by parent/guardian via WeGuide.
Measured: Day 10
Issues with completing questionnaires (as recorded on study-specific questionnaires) - reports by frequency
As reported in the follow-up questionnaires completed by parent/guardian via WeGuide.
Measured: Day 28
Number of parents/participants who expressed no concerns with study procedures
As reported in questionnaires completed by parent/guardian via WeGuide.
Measured: Day 28
Acceptability of the study procedures as measured by a study-specific targeted questionnaire
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.
Measured: Day 28
Number of parents willing to be contacted regarding joining a parent group
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.
Measured: Day 28
Number of parents/participants who completed all study-specific procedures
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)
Measured: Day 28
Secondary outcomes (9)
Agreement between reports of fever recorded by the Garmin Tracker versus the daily questionnaire - measured using Cohen's kappa coefficient
As assessed by Garmin Tracker and study-specific daily questionnaires completed by parent/guardian via WeGuide
Measured: 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
As assessed by Garmin Tracker and in study-specific daily questionnaires completed by parent/guardian via WeGuide
Measured: 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
As assessed by Garmin Tracker and in study specific daily questionnaires completed by parent/guardian via WeGuide
Measured: Baseline to Day 10
Number of participants who re-start antibiotics within 28 days of antibiotic commencement as reported in study-specific questionnaire
As reported in the study-specific day 28 follow-up questionnaire completed by parent/guardian via WeGuide.
Measured: Day 28
Number of participants who are still unwell at Day 28 as reported in study-specific questionnaire
As reported in the study-specific day 28 follow-up questionnaire completed by parent/guardian via WeGuide.
Measured: Day 28
Number of participants who finished complete course of antibiotics as reported in study-specific questionnaire
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
Measured: Day 14
Number of reported doses of antibiotics administered versus doses prescribed as reported in study-specific questionnaire
As reported in study-specific daily questionnaires completed by parent/guardian via WeGuide
Measured: Day 10
Number of participants who report stopping antibiotics early due to resolution of symptoms - as reported on the study-specific questionnaire
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.
Measured: Day 14
Reason for stopping antibiotics early as reported on study-specific questionnaire
As reported in the study-specific day 14 follow-up questionnaire completed by parent/guardian via WeGuide.
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start16 Sep 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a largely observational study with a small device feasibility portion. The primary outcome of the study is looking at feasibility and satisfaction of study instruments. In addition, approximately 60 of the anticipated total of 300 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 surveys) in order to determine level of agreement and investigate if further research into the devices use may be useful.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Children's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093749
- Sponsor's protocol ID
- 116407
- Acronym
- PATSy
- Status last verified
- Oct 2026
- First submitted
- 10 Jul 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.