ACTRN12616000046404已完成4 期
A multi-centre double-blind randomised controlled trial to determine if a longer duration of amoxicillin-clavulanic acid (compared to shorter duration) improves the short and long term clinical outcomes of children hospitalised with community-acquired pneumonia, in Indigenous children and a developing country
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 324
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 3 Months 至 6 Years（—）
- 性别
- All
入选标准
- •1) Hospitalised children aged 3-mo to <6-yrs (in Darwin, children have to be Indigenous)
- •(2) Have features of severe pneumonia on admission (temperature >37.50C or a history of fever at home or observed at the referring clinic, age-adjusted tachypnoea [RR>50 if <12-mo; RR>40 if >12-mo] with chest wall recession and/or SpO2 <92% in air), and consolidation on CXR as diagnosed by treating clinician
- •(3) After 1-3 days of IV antibiotics, are afebrile, with improved respiratory symptoms and signs, SpO2 >90% in air and are ready to be switched to oral amoxicillin-clavulanate, and
- •(4) Have symptoms of no longer than 7 days at point of hospitalisation.
- •(5) Recruited within 24 hours of admission to ward
排除标准
- •(1) Current wheeze
- •(2) Underlying chronic illness other than asthma (e.g. bronchiectasis, cyanotic congenital heart disease or cardiac failure, neuromuscular disorders, immunodeficiency) that could potentially influence the current illness
- •(3) Severe malnutrition (weight-for-height Z-score <-3)
- •(4) Complicated (effusion, empyema or abscess) pneumonia, including tuberculosis
- •(5) Extra-pulmonary infection requiring antibiotic therapy (e.g. meningitis)
- •(6) Beta-lactam allergy
- •(7) Previously enrolled
- •(8) Lack a mobile phone and/or unable to return for follow-up clinic visits during the next 24 months
研究者
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