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| Name | Class |
|---|---|
| Royal Children's Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | Oral antibiotics for the duration of the child's symptoms (minimum 3 days IV plus oral) |
|
| Control arm | Active Comparator | Oral antibiotics for the duration of the prescribed course (as per RCH Clinical Practice Guidelines for each infection) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiotics for duration of symptoms | Drug | Antibiotics for duration of child's symptoms |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 14 & Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| A/Prof Penelope Bryant | Contact | +61383416200 | penelope.bryant@rch.org.au | |
| Lucy Hill | Contact | +61383416200 | lucy.hill@mcri.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| A/Prof Penelope Bryant | Murdoch Childrens Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Children's Hospital | Melbourne | Victoria | 3052 | Australia |
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.
12 months following analysis and publication of the subsequent planned clinical trial.
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.
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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)
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| Antibiotics for duration of prescribed course | Drug | Antibiotics for the duration of the prescribed course |
|
| 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. | Day 10 |
| The number of days taking oral antibiotics [baskets 1-4] | Collected via REDCap study-specific surveys from enrolment to day 28. | 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. | 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. | 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. | 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. | Day 180 |
| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D002481 | Cellulitis |
| D012141 | Respiratory Tract Infections |
| D008199 | Lymphadenitis |
| D007239 | Infections |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012140 | Respiratory Tract Diseases |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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