BonE and Joint Infections - Simplifying Treatment in Children Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 285
- 试验地点
- 10
- 主要终点
- Proportion of children assessed as having made a full recovery 3 months
研究概览
简要总结
This is a multi- centre trial of children with bone and joint infections (BJIs) at eight major paediatric hospitals in Australia and New Zealand. The primary objective is to establish if in children with acute, uncomplicated BJIs, entirely oral antibiotic treatment is not inferior to initial intravenous (IV) treatment for 1 to 7 days followed by an oral antibiotic course in achieving full recovery 3 months after presentation. Children will be randomly allocated to the 'entirely oral antibiotic' group or the 'standard treatment' group.
详细描述
Children with acute onset BJIs who present to the participating sites will be enrolled into the trial if eligible (see eligibility criteria) and randomly allocated into two groups. Children in the 'standard treatment group' will receive standard treatment for BJIs, which consists of IV antibiotics for 1-7 days followed by 3 weeks of oral antibiotics. Children in the 'entirely oral treatment group' will receive high dose oral antibiotics, followed by the standard dose of oral antibiotics for 3 weeks. The outcomes of children in each of the two groups will be compared to determine whether BJIs can be treated without needing a course of IV antibiotics.
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
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 1 to 18 years with acute, uncomplicated, community-acquired bone and joint infection who fulfil pre-defined clinical criteria.
排除标准
- •Infection due to bacteria resistant to cefalexin or atypical infection (e.g. mycobacterial, fungal)
- •Features of sepsis as defined by the presence of organ dysfunction (defined using definitions within the Pediatric Logistic Organ Dysfunction-2 (PELOD-2) score)
- •Concomitant severe, invasive infection e.g. necrosing fasciitis
- •Complicated infection (e.g. presence of prosthetic material; large subperiosteal (>3mm) or soft tissue abscess without surgical intervention; infection secondary to or complicated by trauma)
- •History of allergy to cephalosporin antibiotics or immediate, severe reaction to penicillins
- •Received more than three IV or oral dose of an antibiotic with activity against the likely bacteria causing the current infection
- •Prior episode of OM or SA
- •Prior condition predisposing to poor absorption (e.g. inflammatory bowel disease, current gastrointestinal symptoms) or complicated disease (e.g. immunodeficiency)
- •Prior enrolment in the trial
- •Current recipient of another investigational product as part of a clinical trial
研究组 & 干预措施
Intervention
Children will receive high-dose oral cefalexin 37.5 mg/kg/dose (max 1.5 g) QID 1 to 7 days followed by oral cefalexin 45 mg/kg/dose (max 1.5 g) TDS for a total course of 3 weeks
干预措施: Oral cefalexin only (Drug)
Standard Therapy
Children will receive IV cefazolin 50 mg/kg/dose (max 2 g) three-times daily (TDS) or IV flucloxacillin 50 mg/kg/dise (max 2 g) four-times daily (QID) for 1 to 7 days followed by oral cefalexin 45 mg/kg/dose (max 1.5 g) three-times daily (TDS) for a total course of 3 weeks
干预措施: IV cefazolin or IV flucloxacillin followed by oral cefalexin (Drug)
结局指标
主要结局
Proportion of children assessed as having made a full recovery 3 months
时间窗: 3 months
Full recovery is defined by the absence of: (i) Clinical features of osteomyelitis or septic arthritis (ii) No episodes of disease recurrence requiring further antibiotic administration after initial treatment. Assessment made by a qualified paediatrician.
次要结局
- Proportion of children with with recurrent disease at 12 months.(12 months)
- Proportion of children with complications of their disease at 12 months.(12 months)
- Quality of life - Child Health Utility Scale (CHU9D) Day 8-14(Once between Day 8 to Day 14)
- Quality of life - EQ-5d Day 8-14(Once between Day 8 to Day 14)
- Cost effectiveness - cost-effectiveness ratio of all resources at 12 months(12 months)
- Treatment adherence - medication reconciliation at 3 weeks(Week 3)
- Proportion of children with with recurrent disease at 6 months.(6 months)
- Proportion of children with complications of their disease at 3 months.(3 months)
- Quality of life - Child Health Utility Scale (CHU9D) 12 months(12 months)
- Treatment adherence - Medication Adherence Response Scale at 3 weeks(Week 3)
- Proportion of children with treatment-related adverse effects (AEs).(Between Day 1-7)
- Quality of life - Pediatric Quality of Life Inventory (PedsQL) 3 months(3 months)