A Phase 4 interventional study of Antibiotics for duration of symptoms and Antibiotics for duration of prescribed course in Urinary Tract Infection, Cellulitis and Respiratory Tract Infections, sponsored by Murdoch Childrens Research Institute. Recruiting at 1 site in Australia. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Murdoch Childrens Research Institute · Phase 4, Interventional, and Treatment
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:
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.
This is a single-centre, basket, randomised controlled trial (RCT). There are four baskets in the trial related to infection type - cellulitis (basket 1), urinary tract infection (UTI) (basket 2), lower respiratory tract infection (LRTI) (basket 3) and lymphadenitis (basket 4). The primary objective (related to non-inferiority of efficacy) will be evaluated in children with cellulitis (basket 1) and the trial is powered for this objective. Secondary objectives related to feasibility will be evaluated in baskets 2-4 and will be used to inform a larger multi-site RCT to evaluate efficacy in these populations.
Children admitted to the Royal Children's Hospital (RCH) who are initially treated with IV antibiotics will be enrolled, and will then be switched to oral antibiotics to complete treatment for their infection. In all baskets, children in intervention arms will stop antibiotics when symptoms stop, children in control arms will finish their course of antibiotics as prescribed as standard of care. Recruitment will start with patients on the Hospital in the Home (HITH) program, and progress to including patients from inpatient wards who will be monitored through the clinical governance of HITH.
803 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.
This study's planned enrollment of 200 is above the median of 131 across 560 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →Murdoch Childrens Research Institute is the lead sponsor of 99 studies on the registry; 34 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral antibiotics for the duration of the child's symptoms (minimum 3 days IV plus oral)
Drug: Antibiotics for duration of symptoms
Oral antibiotics for the duration of the prescribed course (as per RCH Clinical Practice Guidelines for each infection)
Drug: Antibiotics for duration of prescribed course
Antibiotics for duration of child's symptoms
Antibiotics for the duration of the prescribed course
The proportion of children with clinical failure within 28 days of initial dose of antibiotics, defined as the requirement to restart antibiotics (either IV or oral) due to the reoccurrence of symptoms attributable to study condition [basket 1]
The need to restart antibiotics will be assessed by a clinician independent of the study (e.g. General practitioner \[GP\], HITH or Emergency Department \[ED\] clinician). The need to restart antibiotics will be documented on the follow up study-specific survey via REDCap and will be completed by the parent/guardian at 14 and 28 days.
Time frame: Day 14 & Day 28
The proportion of children with clinical failure within 28 days of initial dose of antibiotics defined as the requirement to restart antibiotics (either IV or oral) due to the reoccurrence of symptoms attributable to study condition [basket 2-4]
The need to restart antibiotics will be assessed by a clinician independent of the study (e.g. GP, HITH or ED clinician). The need to restart antibiotics will be documented on the study-specific follow up survey in REDCap, which will be completed by the parent/guardian at 14 and 28 days.
Time frame: Day 14 & Day 28
The proportion of children who, after telehealth review, can stop antibiotics early i.e. at the time of symptom resolution [baskets 1-4]
For participants in the intervention arm, once symptom resolution is recorded by parent/guardian on the REDCap study-specific daily survey, this will trigger a telehealth review with a HITH clinician or research nurse who will provide consent for antibiotics to be ceased which will then be recorded in REDCap.
Time frame: Day 10
The number of days taking oral antibiotics [baskets 1-4]
Collected via REDCap study-specific surveys from enrolment to day 28.
Time frame: Baseline to Day 28
The proportion of children with antimicrobial resistant [AMR] pathogens (ESBL or MRSA) on day 28 [baskets 1-4]
Culture-based testing (e.g. chromogenic media) will be used to identify pathogens. Sample will be taken as close to 28 days as possible within reason. The date and time of sample collection will be recorded in REDCap.
Time frame: Day 28
The number of adverse events [baskets 1-4]
Adverse events (e.g. rash, diarrhoea and medication errors) will be recorded from enrolment through to 14 days on the REDCap database.
Time frame: Baseline to Day 14
The proportion of children with parent-reported reoccurrence of study condition within six months of initial antibiotic dose [baskets 1-4]
As reported by parents in the study-specific follow-up survey at six months.
Time frame: Day 180
The proportion of children with parent reported occurrence of any AMR infection within 6 months of initial antibiotic dose [baskets 1-4]
As reported by parents in the study-specific follow-up survey at six months.
Time frame: Day 180
Plan to share: Yes — Individual participant data that underlie the results that are published after de-identification (text, tables, figures and appendices) will be made available long-term for use by future researchers from a recognised research institution who meet access criteria as outlined below.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: 12 months following analysis and publication of the subsequent planned clinical trial.
Access criteria: Researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions for access.
Data sharing details ↗ · www.mcri.edu.au
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Murdoch Childrens Research Institute