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NCT Number: NCT07532941

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

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.

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Key information

Conditions

Urinary Tract Infection Cellulitis Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hemic and Lymphatic Diseases Infections Inflammation Lymphadenitis Lymphatic Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Antibiotics for duration of symptoms

Drug

Antibiotics for duration of child's symptoms

Antibiotics for duration of prescribed course

Drug

Antibiotics for the duration of the prescribed course

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]

    Time frame: Day 14 & Day 28

    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.

Secondary 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 2-4]

    Time frame: Day 14 & Day 28

    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.

  2. The proportion of children who, after telehealth review, can stop antibiotics early i.e. at the time of symptom resolution [baskets 1-4]

    Time frame: Day 10

    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.

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

    Time frame: Baseline to Day 28

    Collected via REDCap study-specific surveys from enrolment to day 28.

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

    Time frame: Day 28

    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.

  5. The number of adverse events [baskets 1-4]

    Time frame: Baseline to Day 14

    Adverse events (e.g. rash, diarrhoea and medication errors) will be recorded from enrolment through to 14 days on the REDCap database.

  6. The proportion of children with parent-reported reoccurrence of study condition within six months of initial antibiotic dose [baskets 1-4]

    Time frame: Day 180

    As reported by parents in the study-specific follow-up survey at six months.

  7. The proportion of children with parent reported occurrence of any AMR infection within 6 months of initial antibiotic dose [baskets 1-4]

    Time frame: Day 180

    As reported by parents in the study-specific follow-up survey at six months.

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

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)

Acronym: StopStop@HITH

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

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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