Study Comparing Stopping Oral Antibiotics When Symptoms End Versus Finishing the Course in Children with Bacterial Infections Treated Through Hospital-in-the-Home

What this Trial Is About

Researchers are evaluating whether stopping oral antibiotics when symptoms stop is as effective as completing the full prescribed course in children who have been treated with intravenous antibiotics for infections such as cellulitis, urinary tract infection UTI, lower respiratory tract infection LRTI, and lymphadenitis. This study is a phase 4, single-center, basket randomized controlled trial conducted at the Royal Childrens Hospital. It aims to determine if oral antibiotics can safely be stopped early in children with cellulitis and assess the feasibility of a larger study involving other infections. Participants will be randomly assigned to one of two groups those who stop oral antibiotics when symptoms resolve after completing at least 3 days of intravenous plus oral antibiotics, and those who finish the full course as per clinical guidelines. The study includes four groups based on infection type and begins with patients in the Hospital in the Home HITH program, expanding to inpatient wards. Daily symptom tracking is done by parents or guardians, and telehealth appointments are conducted once symptoms resolve. During the study, parents will complete a daily symptom diary while their child takes oral antibiotics and attend telehealth follow-ups after symptom resolution. Additional surveys occur on days 14, 28, and 180 to monitor clinical outcomes, reoccurrence, antibiotic use duration, antimicrobial resistance, and adverse events. The main outcome is the proportion of children who experience clinical failure within 28 days, defined as needing to restart antibiotics due to symptom return. The total study duration spans up to six months for follow-up assessments.

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