Phase 4 Trial Comparing Symptom-Based vs. Full-Course Antibiotic Stop Rules in Children
Summary
NIH has registered a Phase 4 clinical trial (NCT07532941) at the Royal Children's Hospital evaluating whether oral antibiotics can be safely stopped when symptoms resolve in children who have completed IV antibiotic courses for cellulitis, UTI, LRTI, and lymphadenitis. The two-arm study compares symptom-triggered antibiotic cessation against traditional full-course completion. Participants complete daily symptom trackers with telehealth follow-up at symptom resolution, plus surveys at days 14, 28, and 180. The trial seeks to determine if abbreviated oral antibiotic courses are non-inferior to completing prescribed durations.
What changed
NIH registered a new Phase 4 clinical trial on ClinicalTrials.gov examining whether oral antibiotics can be safely discontinued when symptoms resolve in pediatric patients who have completed intravenous antibiotic therapy. The randomized study covers four infection types (cellulitis, UTI, LRTI, lymphadenitis) with a symptom tracker intervention arm versus standard full-course completion. Follow-up occurs at 14, 28, and 180 days.
Healthcare providers and clinical researchers should note this trial may inform future antimicrobial stewardship guidelines and prescribing practice standards. Results could influence how pediatric antibiotic protocols are structured, potentially supporting shorter treatment durations aligned with symptom resolution rather than fixed courses. Pharmaceutical companies with pediatric antibiotic formulations may benefit from monitoring trial outcomes.
Archived snapshot
Apr 16, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Clinical Efficacy of Stopping Oral Antibiotics When Symptoms Stop, Compared to 'Finishing the Course'
Phase 4 NCT07532941 Kind: PHASE4 Apr 16, 2026
Abstract
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.
Conditions: Urinary Tract Infection, Cellulitis, Respiratory Tract Infections, Lymphadenitis
Interventions: Antibiotics for duration of symptoms, Antibiotics for duration of prescribed course
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