RECRUITING Phase 4 ClinicalTrials.gov

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

Sponsor: Murdoch Childrens Research Institute • ClinicalTrials.gov ID: NCT07532941

Registry updated: 2026-08-21

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Description

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.

Interventions

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

Eligibility criteria

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

Conditions

Urinary Tract Infection Cellulitis Respiratory Tract Infections Lymphadenitis

Locations

Royal Children's Hospital — Melbourne, Victoria, Australia

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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