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NCT Number: NCT07093749

Perspectives on Antibiotics and Tracking Symptoms in Children

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).

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Key information

Conditions

Urinary Tract Infection Bacterial Infections Bacterial Infections and Mycoses Cellulitis Connective Tissue Diseases Ear Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gram-Positive Bacterial Infections Impetigo Infections Inflammation Male Urogenital Diseases Otitis Otitis Media Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngitis Respiratory Tract Diseases Respiratory Tract Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Staphylococcal Infections Staphylococcal Skin Infections Stomatognathic Diseases Streptococcal Infections Suppuration Tonsillitis Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Children's Hospital

Melbourne, Victoria, 3052, Australia

Location status: Recruiting

Location contact

A/Prof Penelope Bryant

CONTACT

[email protected]

+61393455522

A/Prof Penelope Bryant

PRINCIPAL_INVESTIGATOR

Lucy Hill

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Garmin Smartwatch

Device

Garmin Venu 3 - Worn for the duration of antibiotic course

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Percentage of completed study-specific questionnaires

    Time frame: Baseline through to Day 28

    All study specific questionnaires completed by parent/guardian via WeGuide

  7. 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.

  8. 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.

  9. 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.

  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.

  11. 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.

  12. 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.

  13. 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.

  14. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

A/Prof Penelope Bryant

CONTACT

[email protected]

+61383416200

Lucy Hill

CONTACT

[email protected]

+61383416200

Sponsors and collaborators

Lead sponsor

Murdoch Childrens Research Institute

Other

Collaborators

  • Royal Children's Hospital

Registry information

Official study title

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

Acronym: PATSy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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