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AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
Are there results?
Not yet: the study is under way

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
  • Royal Children's Hospital

    Melbourne, Victoria, 3052

    A/Prof Penelope Bryant, +61393455522, penelope.bryant@rch.org.au

    Lucy Hill, lucy.hill@mcri.edu.au

    Recruiting

Other trials in Australia

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.

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 groups in NCT07093749
Study groupRoleWhat they receive
Intervention armExperimentalAll 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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Percentage of completed study-specific questionnaires

    All study specific questionnaires completed by parent/guardian via WeGuide

    Measured: Baseline through to Day 28

  7. 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

  8. 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

  9. 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

  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

  11. Number of parents/participants who expressed no concerns with study procedures

    As reported in questionnaires completed by parent/guardian via WeGuide.

    Measured: Day 28

  12. 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

  13. 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

  14. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

  1. First posted30 Jul 2025
  2. Study start16 Sep 2025
  3. Primary completionNov 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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)
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.

Questions about this trial

What is this clinical trial studying?

A study testing Garmin Smartwatch in people with Urinary Tract Infection and Cellulitis, run by Murdoch Childrens Research Institute at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact A/Prof Penelope Bryant (+61383416200, penelope.bryant@rch.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of days Garmin Tracker was worn during antibiotic course (time frame: Baseline through to Day 10). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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