Clinical Efficacy of Stopping Oral Antibiotics When Symptoms Stop, Compared to 'Finishing the Course'

NCT07532941 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 123383
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Tract Infection; Cellulitis; Respiratory Tract Infections; Lymphadenitis

Keywords

Infection; Antibiotics; Paediatrics; Symptom Guided

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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]

  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]

  Day 10

• The number of days taking oral antibiotics [baskets 1-4]

  Baseline to Day 28

• The proportion of children with antimicrobial resistant [AMR] pathogens (ESBL or MRSA) on day 28 [baskets 1-4]

  Day 28

• The number of adverse events [baskets 1-4]

  Baseline to Day 14

Study Arms (2)

Intervention arm

EXPERIMENTAL

Oral antibiotics for the duration of the child's symptoms (minimum 3 days IV plus oral)

Drug: Antibiotics for duration of symptoms

Control arm

ACTIVE COMPARATOR

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

Interventions

Antibiotics for duration of prescribed course DRUG

Antibiotics for the duration of the prescribed course

Control arm

Antibiotics for duration of symptoms DRUG

Antibiotics for duration of child's symptoms

Intervention arm

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Clinician determined need for \>10-day oral antibiotic course
• Child with immunosuppression (e.g. as a result of cancer treatment)
• Second episode of same bacterial infection within the last 28 days
• Child is unable to take oral antibiotics
• Previous enrolment in StopStop@HITH
• Parent/guardian does not speak English
• Clinician determined need for 10-day course of oral antibiotics for treatment/clearance of streptococcal infection
• UTI only: known impaired renal function (e.g. renal transplant patients or known chronic renal failure)
• 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

Sponsors & Collaborators

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

Study Sites (1)

Royal Children's Hospital

Melbourne, Victoria, 3052, Australia

Location

MeSH Terms

Conditions

Urinary Tract Infections; Cellulitis; Respiratory Tract Infections; Lymphadenitis; Infections

Interventions

Anti-Bacterial Agents

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; Respiratory Tract Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• A/Prof Penelope Bryant

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

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: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within each basket children will be randomised to two arms: Intervention: oral antibiotics for the duration of the child's symptoms (minimum 3 days IV plus oral) Control: oral antibiotics for the duration of the prescribed course (as per RCH Clinical Practice Guidelines for each infection)

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 16, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

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)