An interventional study of Garmin Smartwatch in Urinary Tract Infection, Cellulitis and Impetigo, sponsored by Murdoch Childrens Research Institute. Recruiting at 1 site in Australia. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Murdoch Childrens Research Institute · Not applicable, Interventional, and Other
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).
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.
803 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.
This study's planned enrollment of 300 is above the median of 131 across 560 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →Murdoch Childrens Research Institute is the lead sponsor of 99 studies on the registry; 34 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Parent/guardian does not speak English
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 14
Percentage of completed study-specific questionnaires
All study specific questionnaires completed by parent/guardian via WeGuide
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 28
Number of parents/participants who expressed no concerns with study procedures
As reported in questionnaires completed by parent/guardian via WeGuide.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: Day 28
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Day 14
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: 12 months following analysis and publication of the subsequent planned clinical trial.
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.
Data sharing details ↗ · www.mcri.edu.au
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Murdoch Childrens Research Institute