Initial Oral Antibiotics for Bone and Joint Infections in Children: A Prospective Nationwide Real-world Effectiveness Study in Denmark
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Clinical sequelae at 6 months
研究概览
简要总结
Initial oral antibiotic treatment for children and adolescents with uncomplicated bone and joint infections (BJI) has been found non-inferior to initial IV antibiotics in one randomized controlled trial (RCT). The real-world effectiveness of initial oral antibiotics for children and adolescents with BJI is unclear.
This nationwide, prospective, multicenter, real-world cohort study aims to compare the effectiveness and safety of initial oral antibiotic treatment for children and adolescents with uncomplicated BJI in a real-world setting with those who received initial oral antibiotics in our RCT.
详细描述
Background:
Initial oral antibiotic treatment for children and adolescents with uncomplicated BJI has been found non-inferior to initial IV antibiotics in one randomized controlled trial (RCT) from Denmark. The real-world effectiveness of initial oral antibiotics for children and adolescents with BJI is unclear. In Denmark, initial oral antibiotics were allowed in nationwide guidelines for children and adolescents aged 3 months to 17 years with uncomplicated BJI from 2024.
Aim:
We aim to compare the effectiveness and safety of initial oral antibiotics for children and adolescents with uncomplicated BJI in a real-world setting with those who received initial oral antibiotics in our RCT.
Study design:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Children and adolescents with bone and joint infections treated with initial oral antibiotics
Patients with uncomplicated bone and joint infections treated with initial oral antibiotics.
According to Danish Nationwide Guidelines (initiated in 2024), initial oral antibiotics are recommended to patients with no risk factors for complicated disease. Risk factors include for complicated disease include:
- Severe illness or sepsis
- Rapid symptom progression
- Pronounced symptoms, including severe pain
- Pronounced soft tissue involvement
- Foreign material or post-surgical infection
- Infection with a resistent or rare pathogen, e.g., Salmonella or MRSA
- Severe comorbidity, including immunodeficiency
Patients who have received intravenous antibiotic therapy for less than 24 h before oral antibiotics will be included
干预措施: Oral antibiotic treatment (Drug)
结局指标
主要结局
Clinical sequelae at 6 months
时间窗: 6 months after end of treatment [4-9 months]
Clinical sequelae is defined as any abnormal mobility or function of the affected bone or joint. Clinical sequelae will be evaluated through a structured medical telephone interview at 6 months with a parent or a guardian (or the patient, if adolescent, along with the parent). If the medical interview raises any concerns about abnormal mobility or function of the affected bone or joint, or if the patient is scheduled for a clinical consultation, clinical sequelae will be evaluated by a clinical examination performed by a pediatrician or an orthopedic surgeon.
次要结局
- Suspicion of treatment failure within 28 days(28 days after initiation of treatment)
- Full recovery after initiation of treatment(Within 3 months after initiation of treatment (0-4 months))
- Recurrent infection within 6 months(6 months after the end of treatment)
- Clinical sequelae at 12 months(12 months after the end of treatment [9-16 months])
- Sequelae at 5 years(5 years after the end of treatment [4-6 years])
研究者
Ulrikka Nygaard
Ass Professor, Consultant, PhD, MD, MPhil
Rigshospitalet, Denmark