Perspectives on Antibiotics and Tracking Symptoms in Children

NCT07093749 | Recruiting

• 1 other identifier: 116407
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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). 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).

Conditions

Urinary Tract Infection; Cellulitis; Impetigo; Pharyngitis; Tonsillitis; Respiratory Tract Infections; Otitis Media

Keywords

Paediatrics; Antibiotics; Digital Health; Infection

Outcome Measures

Primary Outcomes (14)

• 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.

  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.

  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.

  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.

  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.

  Day 14

• Percentage of completed study-specific questionnaires

  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

  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

  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

  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

  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

  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

  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

  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

  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 Outcomes (9)

• Agreement between reports of fever recorded by the Garmin Tracker versus the daily questionnaire - measured using Cohen's kappa coefficient

  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

  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

  Baseline to Day 10

• Number of participants who re-start antibiotics within 28 days of antibiotic commencement as reported in study-specific questionnaire

  Day 28

• Number of participants who are still unwell at Day 28 as reported in study-specific questionnaire

  Day 28

Study Arms (1)

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).

Device: Garmin Smartwatch

Interventions

Garmin Smartwatch DEVICE

Garmin Venu 3 - Worn for the duration of antibiotic course

Intervention arm

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• \- Parent/guardian does not speak English

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead
• Royal Children's Hospital: collaborator

Study Sites (1)

Royal Children's Hospital

Melbourne, Victoria, 3052, Australia

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections; Cellulitis; Impetigo; Pharyngitis; Tonsillitis; Respiratory Tract Infections; Otitis Media; Infections

Condition Hierarchy (Ancestors)

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

Central Study Contacts

A/Prof Penelope Bryant

CONTACT

+61383416200; penelope.bryant@rch.org.au

Lucy Hill

CONTACT

+61383416200; lucy.hill@mcri.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 30, 2025
• Study Start: September 16, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

AU (1)