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

Recruiting now · Phase 4

Conditions studied: Urinary Tract Infection, Cellulitis, Respiratory Tract Infections, Lymphadenitis

In brief

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.

Key facts

Study ID: NCT07532941
Run by: Murdoch Childrens Research Institute
People needed: 200
Starts: 2026-08-01
Expected to finish: 2028-06-01
Last updated by the study team: 2026-08-05

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

Royal Children's Hospital — Melbourne, Victoria, Australia (enrolling)

Full record on ClinicalTrials.gov

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