Clinical Efficacy of Stopping Oral Antibiotics When Symptoms Stop, Compared to 'Finishing the Course' (StopStop@HITH)

StopStop@HITH - Clinical Efficacy of Stopping Oral Antibiotics When Symptoms Stop, Compared to 'Finishing the Course', for Children With Bacterial Infections Through Hospital-in-the-Home (HITH): a Basket Randomised Controlled Trial (RCT)

The aim of the StopStop@HITH study is to see if stopping antibiotics when symptoms stop is as good as finishing the course of antibiotics. The study will enrol children at the Royal Children's Hospital who are prescribed oral antibiotics after completing a course of intravenous (IV) antibiotics for the treatment of cellulitis, urinary tract infection (UTI), lower respiratory tract infection (LRTI) and lymphadenitis.

The aims of the study are:

• To determine if oral antibiotics can be safely stopped once symptoms stop in children with cellulitis (who have completed a course of IV antibiotics).
• To assess feasibility of a larger study of other common infections across multiple hospitals.

The participants parent/guardian will complete a daily symptom tracker for the duration of the prescribed oral antibiotic course and attend a telehealth appointment with the study team once the participants symptoms have resolved. There are additional follow up surveys at day 14, day 28 and day 180.

Study Overview

• Status: Not yet recruiting
• Conditions: Respiratory Tract Infections; Cellulitis; Urinary Tract Infection; Lymphadenitis
• Intervention / Treatment: Drug: Antibiotics for duration of symptoms; Drug: Antibiotics for duration of prescribed course

Detailed Description

This is a single-centre, basket, randomised controlled trial (RCT). There are four baskets in the trial related to infection type - cellulitis (basket 1), urinary tract infection (UTI) (basket 2), lower respiratory tract infection (LRTI) (basket 3) and lymphadenitis (basket 4). The primary objective (related to non-inferiority of efficacy) will be evaluated in children with cellulitis (basket 1) and the trial is powered for this objective. Secondary objectives related to feasibility will be evaluated in baskets 2-4 and will be used to inform a larger multi-site RCT to evaluate efficacy in these populations.

Children admitted to the Royal Children's Hospital (RCH) who are initially treated with IV antibiotics will be enrolled, and will then be switched to oral antibiotics to complete treatment for their infection. In all baskets, children in intervention arms will stop antibiotics when symptoms stop, children in control arms will finish their course of antibiotics as prescribed as standard of care. Recruitment will start with patients on the Hospital in the Home (HITH) program, and progress to including patients from inpatient wards who will be monitored through the clinical governance of HITH.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: A/Prof Penelope Bryant; Phone Number: +61383416200; Email: penelope.bryant@rch.org.au
• Study Contact Backup: Name: Lucy Hill; Phone Number: +61383416200; Email: lucy.hill@mcri.edu.au

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3052
      • Royal Children's Hospital
      • Contact: A/Prof Penelope Bryant; Phone Number: +61383416200; Email: penelope.bryant@rch.org.au
      • Contact: Lucy Hill; Email: lucy.hill@mcri.edu.au
      • Principal Investigator: A/Prof Penelope Bryant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Between the ages of ≥ 1 years and ≤ 17 years at enrolment
2. Diagnosis of cellulitis, urinary tract infection (UTI), lower respiratory tract infection (LRTI) or lymphadenitis
3. Prescription of oral antibiotics as a switch from IV antibiotics

Exclusion Criteria:

1. Clinician determined need for >10-day oral antibiotic course
2. Child with immunosuppression (e.g. as a result of cancer treatment)
3. Second episode of same bacterial infection within the last 28 days
4. Child is unable to take oral antibiotics
5. Previous enrolment in StopStop@HITH
6. Parent/guardian does not speak English
7. Clinician determined need for 10-day course of oral antibiotics for treatment/clearance of streptococcal infection
8. UTI only: known impaired renal function (e.g. renal transplant patients or known chronic renal failure)
9. LRTI only: known chronic respiratory condition (e.g. cystic fibrosis or bronchiectasis) or need for long term respiratory support (e.g. home oxygen, Continuous Positive Airway Pressure [CPAP] or tracheostomy); empyema or lung abscess

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; Oral antibiotics for the duration of the child's symptoms (minimum 3 days IV plus oral)	Drug: Antibiotics for duration of symptoms; Antibiotics for duration of child's symptoms
Active Comparator: Control arm; Oral antibiotics for the duration of the prescribed course (as per RCH Clinical Practice Guidelines for each infection)	Drug: Antibiotics for duration of prescribed course; Antibiotics for the duration of the prescribed course

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of children with clinical failure within 28 days of initial dose of antibiotics, defined as the requirement to restart antibiotics (either IV or oral) due to the reoccurrence of symptoms attributable to study condition [basket 1]	The need to restart antibiotics will be assessed by a clinician independent of the study (e.g. General practitioner [GP], HITH or Emergency Department [ED] clinician). The need to restart antibiotics will be documented on the follow up study-specific survey via REDCap and will be completed by the parent/guardian at 14 and 28 days.	Day 14 & Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of children with clinical failure within 28 days of initial dose of antibiotics defined as the requirement to restart antibiotics (either IV or oral) due to the reoccurrence of symptoms attributable to study condition [basket 2-4]	The need to restart antibiotics will be assessed by a clinician independent of the study (e.g. GP, HITH or ED clinician). The need to restart antibiotics will be documented on the study-specific follow up survey in REDCap, which will be completed by the parent/guardian at 14 and 28 days.	Day 14 & Day 28
The proportion of children who, after telehealth review, can stop antibiotics early i.e. at the time of symptom resolution [baskets 1-4]	For participants in the intervention arm, once symptom resolution is recorded by parent/guardian on the REDCap study-specific daily survey, this will trigger a telehealth review with a HITH clinician or research nurse who will provide consent for antibiotics to be ceased which will then be recorded in REDCap.	Day 10
The number of days taking oral antibiotics [baskets 1-4]	Collected via REDCap study-specific surveys from enrolment to day 28.	Baseline to Day 28
The proportion of children with antimicrobial resistant [AMR] pathogens (ESBL or MRSA) on day 28 [baskets 1-4]	Culture-based testing (e.g. chromogenic media) will be used to identify pathogens. Sample will be taken as close to 28 days as possible within reason. The date and time of sample collection will be recorded in REDCap.	Day 28
The number of adverse events [baskets 1-4]	Adverse events (e.g. rash, diarrhoea and medication errors) will be recorded from enrolment through to 14 days on the REDCap database.	Baseline to Day 14
The proportion of children with parent-reported reoccurrence of study condition within six months of initial antibiotic dose [baskets 1-4]	As reported by parents in the study-specific follow-up survey at six months.	Day 180
The proportion of children with parent reported occurrence of any AMR infection within 6 months of initial antibiotic dose [baskets 1-4]	As reported by parents in the study-specific follow-up survey at six months.	Day 180

Collaborators and Investigators

• Sponsor: Murdoch Childrens Research Institute
• Collaborators: Royal Children's Hospital
• Investigators: Principal Investigator: A/Prof Penelope Bryant, Murdoch Childrens Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Infection; Antibiotics; Paediatrics; Symptom Guided
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Connective Tissue Diseases; Respiratory Tract Diseases; Inflammation; Lymphatic Diseases; Skin Diseases, Infectious; Suppuration; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Hemic and Lymphatic Diseases; Infections; Respiratory Tract Infections; Urinary Tract Infections; Cellulitis; Lymphadenitis; Anti-Infective Agents; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Anti-Bacterial Agents
• Other Study ID Numbers: 123383

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 12 months following analysis and publication of the subsequent planned clinical trial.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No