CHOICE Trial: Cellulitis at Home Or Inpatient in Children From ED
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Treatment failure (inadequate clinical improvement, adverse event)
研究概览
简要总结
Many children every year present to the Emergency Department (ED) at The Royal Children's Hospital (RCH) with cellulitis (skin infection). If it is mild, the children can go home with oral antibiotic treatment. If it is complicated and severe, these children are admitted to hospital for intravenous (IV, through a drip) antibiotic treatment. There is a middle group with uncomplicated moderate/severe cellulitis who require IV antibiotics but who are not acutely unwell. In order to determine whether it is just as effective for children with uncomplicated moderate to severe cellulitis to receive antibiotic treatment at home (via Hospital-In-The-Home) as it is to receive antibiotic treatment in hospital, there is a need to conduct a larger study and randomly assign children to receive either HITH or hospital ward care.
The primary research question to be addressed is:
In children with moderate/severe uncomplicated cellulitis, is the failure rate at 2 days following the first dose of antibiotic non-inferior for children treated with IV antibiotics at home compared to the failure rate at 2 days following the first dose for children treated with IV antibiotics in hospital?
详细描述
INTRODUCTION AND BACKGROUND Adults with cellulitis commonly have IV antibiotics administered as outpatients, whereas most children are admitted to hospital. Based on a small amount of literature, it is known that some children with moderate/severe cellulitis can also be safely be treated at home.This study will include all children with uncomplicated moderate/severe cellulitis and will therefore demonstrate whether all children with uncomplicated moderate/severe cellulitis can be effectively treated at home.
If the study demonstrates that it is just as effective to treat these children in the home, it has the potential to impact on the child and family's quality of life (QOL) as well as hospital resource management.
PRIMARY OBJECTIVE To compare the failure rate of IV antibiotic treatment of children treated at home (iv ceftriaxone) with those treated in hospital (iv flucloxacillin) in the first 2 days of treatment following the first dose given in the ED in children with moderate/severe cellulitis (Moderate/severe: defined in this study, as those assessed by ED doctor to need iv antibiotics)
SECONDARY OBJECTIVES
To compare:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 6 months to 18 years
- •Children presenting to RCH ED with moderate/severe cellulitis
- •Moderate/severe: defined in this study, as those assessed by ED clinician to need IV antibiotics
- •Reasons for starting IV antibiotics include:
- •Failed oral therapy (not improving despite 24h of oral therapy)
- •Rapidly spreading redness (from patient/parent history)
- •Significant swelling/redness/pain
- •Systemic symptoms/signs (eg. fever, lethargy)
- •Difficult to treat areas (eg. face, ear, toe)
排除标准
- •Children will be excluded:
- •With orbital cellulitis or unable to exclude orbital cellulitis,
- •With penetrating injury/bites,
- •With suspected fasciitis or myositis,
- •With toxicity: tachycardia when afebrile or hypotension (both as per the limits set out by RCH Resuscitation Card), poor central perfusion (capillary refill >2 seconds)
- •With immunosuppression,
- •With varicella,
- •With suspected/confirmed foreign body,
- •With abscess not drained,
- •With dental abscess,
- •With concurrent sinusitis or otitis media or lymphadenitis necessitating different antibiotic treatment to flucloxacillin monotherapy or ceftriaxone monotherapy,
- •With liver co-morbidities
- •With other medical diagnoses warranting admission to hospital for observation or treatment relating to the known medical condition
- •With difficult intravenous access,
- •Age <6 months old,
- •Who could be managed on oral antibiotics (ie assessed as mild cellulitis)
研究组 & 干预措施
Home
Patients will be treated at home through the Hospital-In-The-Home program with intravenous once daily ceftriaxone (50mg/kg once daily), administered by a nurse/doctor visiting once daily.
干预措施: Home (Other)
Home
Patients will be treated at home through the Hospital-In-The-Home program with intravenous once daily ceftriaxone (50mg/kg once daily), administered by a nurse/doctor visiting once daily.
干预措施: ceftriaxone (Drug)
Ward
Patients will be admitted to hospital ward and treated with six hourly flucloxacillin (50mg/kg), administered by a ward nurse as per routine practice.
干预措施: Ward (Other)
Ward
Patients will be admitted to hospital ward and treated with six hourly flucloxacillin (50mg/kg), administered by a ward nurse as per routine practice.
干预措施: flucloxacillin (Drug)
结局指标
主要结局
Treatment failure (inadequate clinical improvement, adverse event)
时间窗: Within 2 days of commencing empiric antibiotic
The primary outcome is failure of treatment defined as no clinical improvement of cellulitis within 2 days of treatment from the start of the first antibiotic dose given in the ED. Any change of initial empiric antibiotics within 2 days from commencement due to: * inadequate clinical improvement or * adverse events as determined by treating physician will be considered a treatment failure.
次要结局
- Representation to ED(28 days)
- Adverse events(14 days)
- Time to no progression(Within 3 days)
- Readmission rate(28 days)
- ED Length of stay(2 days)
- IV cannula resiting (Rates of iv cannula needing at least one resiting)(14 days)
- Cellulitis clinical score(14 days)
- Comparing patient costs(14 days)
- Microbiology(1 year)
- Time to discharge(14 days)
- Duration of iv antibiotics(14 days)
- Complications of cellulitis (Development of abscess requiring drainage)(14 days)
- Quality of life (QOL) indicators(1 year)
研究者
Laila Ibrahim
Dr Laila Ibrahim, MBBChBAO, PhD Student
Murdoch Childrens Research Institute