NCT07532941 Clinical Efficacy of Stopping Oral Antibiotics When Symptoms Stop, Compared to 'Finishing the Course'
| NCT ID | NCT07532941 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Murdoch Childrens Research Institute |
| Condition | Urinary Tract Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-08-18 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 200 participants in total. It began in 2026-08-18 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
A/Prof Penelope Bryant
PRINCIPAL INVESTIGATOR
Murdoch Childrens Research Institute
Frequently Asked Questions
Who can join the NCT07532941 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 17 Years, studying Urinary Tract Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07532941 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07532941 currently recruiting?
Yes, NCT07532941 is actively recruiting participants. Contact the research team at penelope.bryant@rch.org.au for enrollment information.
Where is the NCT07532941 trial being conducted?
This trial is being conducted at Melbourne, Australia.
Who is sponsoring the NCT07532941 clinical trial?
NCT07532941 is sponsored by Murdoch Childrens Research Institute. The principal investigator is A/Prof Penelope Bryant at Murdoch Childrens Research Institute. The trial plans to enroll 200 participants.