Stop antibiotics early when symptoms stop in kids after IV treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-centre, basket randomized trial at the Royal Children’s Hospital. Children switch from IV to oral antibiotics and are randomized to stop antibiotics when symptoms stop versus completing the prescribed course. The primary focus is on cellulitis with non-inferiority of stopping early; secondary aims explore feasibility for broader use across other infections. Parents/guardians track symptoms daily and participate in telehealth check-ins, with follow-ups at days 14, 28, and 180. The study informs whether a symptom-guided stopping strategy could reduce antibiotic exposure without compromising safety.

Why it matters

Who can join: the full rules

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

Where it's running

• Royal Children's Hospital
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Principal investigator: A/Prof Penelope Bryant — Murdoch Childrens Research Institute
• Study coordinator: A/Prof Penelope Bryant
• Email: penelope.bryant@rch.org.au
• Phone: +61383416200

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.