Urinary Tract InfectionPhase 4StopStop@HITHNCT07532941
Clinical Efficacy of Stopping Oral Antibiotics When Symptoms Stop, Compared to 'Finishing the Course'
A Phase 4 study testing Antibiotics for duration of symptoms and Antibiotics for duration of prescribed course in people with Urinary Tract Infection and Cellulitis, run by Murdoch Childrens Research Institute at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Urinary Tract Infection, Cellulitis, Respiratory Tract Infections
- What is being tested?
- Antibiotics for duration of symptoms and Antibiotics for duration of prescribed course
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteAustralia
- Study dates
- 18 Aug 2026to Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Between the ages of ≥ 1 years and ≤ 17 years at enrolment
- Diagnosis of cellulitis, urinary tract infection (UTI), lower respiratory tract infection (LRTI) or lymphadenitis
- Prescription of oral antibiotics as a switch from IV antibiotics
Who cannot join
- Clinician determined need for >10-day oral antibiotic course
- Child with immunosuppression (e.g. as a result of cancer treatment)
- Second episode of same bacterial infection within the last 28 days
- Child is unable to take oral antibiotics
- Previous enrolment in StopStop@HITH
- Parent/guardian does not speak English
Show all 9Show fewer
- Clinician determined need for 10-day course of oral antibiotics for treatment/clearance of streptococcal infection
- UTI only: known impaired renal function (e.g. renal transplant patients or known chronic renal failure)
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Royal Children's Hospital
Melbourne, Victoria, 3052
A/Prof Penelope Bryant, +61383416200, penelope.bryant@rch.org.au
Lucy Hill, lucy.hill@mcri.edu.au
About this study
Official title: StopStop@HITH - Clinical Efficacy of Stopping Oral Antibiotics When Symptoms Stop, Compared to 'Finishing the Course', for Children With Bacterial Infections Through Hospital-in-the-Home (HITH): a Basket Randomised Controlled Trial (RCT)
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:
Read more
- 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.
Read the detailed description
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.
- Being tested
- Antibiotics for duration of symptoms, Antibiotics for duration of prescribed course
- Keywords
- Infection, Antibiotics, Paediatrics, Symptom Guided
- Medical subject headings
- Urinary Tract Infections, Cellulitis, Respiratory Tract Infections, Lymphadenitis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotics for duration of symptomsDrug
Antibiotics for duration of child's symptoms
Antibiotics for duration of prescribed courseDrug
Antibiotics for the duration of the prescribed course
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Oral antibiotics for the duration of the child's symptoms (minimum 3 days IV plus oral) Receives: Drug: Antibiotics for duration of symptoms |
| Control arm | Active comparator | Oral antibiotics for the duration of the prescribed course (as per RCH Clinical Practice Guidelines for each infection) Receives: Drug: Antibiotics for duration of prescribed course |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 14 & Day 28
Secondary outcomes (7)
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.
Measured: 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.
Measured: Day 10
The number of days taking oral antibiotics [baskets 1-4]
Collected via REDCap study-specific surveys from enrolment to day 28.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start18 Aug 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Within each basket children will be randomised to two arms: Intervention: oral antibiotics for the duration of the child's symptoms (minimum 3 days IV plus oral) Control: oral antibiotics for the duration of the prescribed course (as per RCH Clinical Practice Guidelines for each infection)
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Children's Hospital
- Responsible party
- Sponsor
- Investigators
- A/Prof Penelope Bryant, Principal investigator, Murdoch Childrens Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532941
- Sponsor's protocol ID
- 123383
- Acronym
- StopStop@HITH
- Status last verified
- Aug 2026
- First submitted
- 8 Apr 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- StopStop@HITH - Clinical Efficacy of Stopping Oral Antibiotics When Symptoms Stop, Compared to 'Finishing the Course', for Children With Bacterial Infections Through Hospital-in-the-Home (HITH): a Basket Randomised Controlled Trial (RCT)
- ClinicalTrials.gov ID
- NCT07532941
- Acronym / sponsor ID
- StopStop@HITH / 123383
- Keywords
- Infection, Antibiotics, Paediatrics, Symptom Guided
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Murdoch Childrens Research InstituteUniversity, hospital or other
- Collaborators
- Royal Children's Hospital
- Study start
- 18 Aug 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Within each basket children will be randomised to two arms: Intervention: oral antibiotics for the duration of the child's symptoms (minimum 3 days IV plus oral) Control: oral antibiotics for the duration of the prescribed course (as per RCH Clinical Practice Guidelines for each infection)
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Drug: Antibiotics for duration of symptomsOral antibiotics for the duration of the child's symptoms (minimum 3 days IV plus oral) |
| Control arm | Active comparator | Drug: Antibiotics for duration of prescribed courseOral antibiotics for the duration of the prescribed course (as per RCH Clinical Practice Guidelines for each infection) |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Between the ages of ≥ 1 years and ≤ 17 years at enrolment
- Diagnosis of cellulitis, urinary tract infection (UTI), lower respiratory tract infection (LRTI) or lymphadenitis
- Prescription of oral antibiotics as a switch from IV antibiotics
Key exclusion criteria (9 listed)
- Clinician determined need for >10-day oral antibiotic course
- Child with immunosuppression (e.g. as a result of cancer treatment)
- Second episode of same bacterial infection within the last 28 days
- Child is unable to take oral antibiotics
- Previous enrolment in StopStop@HITH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotics for duration of symptomsAntibiotics for duration of child's symptoms | Drug | Intervention arm |
| Antibiotics for duration of prescribed courseAntibiotics for the duration of the prescribed course | Drug | Control arm |
Primary outcome
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]
Time frame: Day 14 & Day 28
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.
7 secondary outcomes
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]
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]
Time frame: Day 10
The number of days taking oral antibiotics [baskets 1-4]
Time frame: Baseline to Day 28
The proportion of children with antimicrobial resistant [AMR] pathogens (ESBL or MRSA) on day 28 [baskets 1-4]
Time frame: Day 28
The number of adverse events [baskets 1-4]
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]
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]
Time frame: Day 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
A/Prof Penelope Bryant principal investigator
Murdoch Childrens Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antibiotics for duration of symptoms and Antibiotics for duration of prescribed course in people with Urinary Tract Infection and Cellulitis, run by Murdoch Childrens Research Institute at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact A/Prof Penelope Bryant (+61383416200, penelope.bryant@rch.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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] (time frame: Day 14 & Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.