A Multi-centre Double-blind Randomised Controlled Trial to Determine if a Longer Duration of Amoxicillin-clavulanic Acid (Compared to Shorter Duration) Improves Clinical Outcomes of Children Hospitalised With Community-acquired Pneumonia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 314
- 试验地点
- 5
- 主要终点
- The proportion without chronic respiratory symptoms and signs or bronchiectasis.
研究概览
简要总结
An intervention study to determine if a longer duration of antibiotics (compared to shorter duration) improves the short and long term clinical outcomes of children hospitalised for pneumonia
详细描述
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
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalised children aged 3-mo to 5-yrs (in Darwin, children have to be Indigenous)
- •Have features of severe pneumonia on admission (temperature >37.5 celsius or a history of fever at home or observed at the referring clinic, age-adjusted tachypnoea [respiratory rate>50 if <12-months; respiratory rate>40 if >12-months] with chest wall recession and/or oxygen saturation <92% in air), and consolidation on chest X-ray as diagnosed by treating clinician
- •After 1-3 days of IV antibiotics, are afebrile, with improved respiratory symptoms and signs, oxygen saturation>90% in air and are ready to be switched to oral amoxicillin-clavulanate, and
- •Have symptoms of no longer than 7 days at point of hospitalisation.
排除标准
- •Current wheeze
- •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
- •Severe malnutrition (weight-for-height Z-score <-3)
- •Complicated (effusion, empyema or abscess) pneumonia, including tuberculosis
- •Extra-pulmonary infection requiring antibiotic therapy (e.g. meningitis)
- •Beta-lactam allergy
- •Previously enrolled
- •Lack a mobile phone and/or unable to return for follow-up clinic visits during the next 24 months
研究组 & 干预措施
Active arm: Amoxicillin-clavulanic Acid
8 days of oral amoxicillin-clavulanic Acid 400/57 duo formulation (70-90mg/kg/day, twice daily dosing: max 980mg per day)
干预措施: Amoxicillin-clavulanic Acid (Drug)
Placebo arm
8 days of oral placebo (equivalent volume as the active arm)
干预措施: Placebo (for Amoxicillin-clavulanic Acid) (Drug)
结局指标
主要结局
The proportion without chronic respiratory symptoms and signs or bronchiectasis.
时间窗: Clinical review at 24 months (range 23-25 months)
Any further chronic respiratory symptoms and signs or bronchiectasis though the child's medical records (community or hospital) will be captured. These children will be reviewed at 24 months, however many children will reside in geographically isolated locations, thus a range of 23-25 months is a reasonable timeframe to capture clinically important outcomes.
次要结局
- The proportion with clinical cure (i.e. complete resolution of respiratory symptoms and signs).(Clinical review week 4 (range 4-6 weeks))
- Gene expression data(Baseline (hospital admission) and 4-6 weeks (where possible))
- Time to next respiratory-related hospitalisation assessed by chart reviews(Clinical review week 4 (range 4-6 weeks))
- Adverse events(Adverse events monitored while participant taking trial medication)
- Nasopharyngeal bacteria antibiotic resistance patterns(Baseline (admission to hospital, week 4 (range 4-6 weeks) and 12 months (range 12-14 months))