Acute non-severe osteomyelitis in children - Outpatient management strategy with oral antibiotic therapy compared to a standard strategy with conventional hospitalization and intravenous antibiotic therapy: randomized open-label non-inferiority study with Bayesian and medico-economic analyses.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 320
- 试验地点
- 16
- 主要终点
- Complete recovery without relapse at 6 months defined by the absence of clinical signs of osteomyelitis at 6 months AND the absence of secondary septic complications (septic arthritis, perioste abscess) before the end of antibiotic therapy AND the absence of relapse or rehospitalization for osteomyelitis in relation to the initial infection.
研究概览
简要总结
Demonstrate the non-inferiority of an outpatient management strategy versus a standard strategy involving hospitalization on complete recovery without relapse at 6 months after an episode of acute osteomyelitis of the 1-5 year old child without criteria of Gravity
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Children ≥ 1 year old and ≤4 years old;
- •First episode of acute osteomyelitis suspected on clinical grounds (acute functional impotence (<15 days) most often associated with fever) and confirmed in the first days of treatment by bone scintigraphy or MRI
- •Absence of sepsis (absence of hemodynamic disorders, respiratory disorders, impaired consciousness)
- •And absence of subperiosteal abscess or associated arthritis or deep vein thrombosis
- •And absence of scarlatiniform rash
- •And CRP < 50 mg/ml
- •And normal initial bone x-ray (or thickening of soft parts).
排除标准
- •Infections ostéo-articulaires multifocales
- •Sickle cell patients, immunosuppressed
- •Antibiotic treatment in progress or within 48 hours before the emergency room consultation
- •Severe allergy to beta-lactamines
- •Digestive disorders
结局指标
主要结局
Complete recovery without relapse at 6 months defined by the absence of clinical signs of osteomyelitis at 6 months AND the absence of secondary septic complications (septic arthritis, perioste abscess) before the end of antibiotic therapy AND the absence of relapse or rehospitalization for osteomyelitis in relation to the initial infection.
Complete recovery without relapse at 6 months defined by the absence of clinical signs of osteomyelitis at 6 months AND the absence of secondary septic complications (septic arthritis, perioste abscess) before the end of antibiotic therapy AND the absence of relapse or rehospitalization for osteomyelitis in relation to the initial infection.
次要结局
未报告次要终点
研究者
Coordinating investigator
Scientific
Assistance Publique Hopitaux De Paris