NCT02380352已完成4 期
Short-course Antimicrobial Therapy for Paediatric Respiratory Infections
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 281
- 试验地点
- 2
- 主要终点
- Early clinical cure (Resolution of tachypnoea, increased work of breathing, and fever)
研究概览
简要总结
Randomized controlled double-blind non-inferiority clinical trial to determine whether five days of high-dose amoxicillin leads to comparable rates of early clinical cure compared with 10 days of high-dose amoxicillin for previously healthy children with mild community-acquired pneumonia.
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
- 6 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6 months to 10 years presenting with CAP will be eligible. CAP will be defined if all of the four following numeric criteria are met:
- •fever (>37.5 C axillary, > 37.7 C oral, or >38 C rectal) recorded in the ED or at home in the 48h prior to presentation;
- •any one of:
- •tachypnoea on exam (>60 bpm for age <1 y, >50 bpm for 1-2 y of age, >40 bpm for 2-4 y of age, and >30 bpm for >4 y of age);
- •cough on exam or by history;
- •increased work of breathing on exam; or
- •auscultatory findings (focal crackles, bronchial breathing, etc.) consistent with pneumonia;
- •infiltrates on chest radiograph consistent with bacterial CAP as judged by the ED physician; and
- •the attending ED physician diagnoses the child with primary CAP. (Children treated with systemic steroids in the ED will be presumed to have primary asthma exacerbation with possible infection and therefore will not meet inclusion criteria.)
- •Participants must be well enough to be treated as outpatients (discharged home by the ED physician, adequate volume status, able to tolerate oral medication, oxygen saturation > 90%, no evidence of impending respiratory failure), and have no evidence of empyaema or necrotizing pneumonia on chest radiograph.
排除标准
- •Children will be excluded if they have any of the following: cystic fibrosis, anatomic lung disease, bronchiectasis, congenital heart disease, history of repeated aspiration or velopharyngeal incompetence, malignancy, conditions requiring treatment with immune suppressants, primary immunodeficiency, advanced HIV infection, prolonged admissions (>48 h) to hospital within the past 2 months, pneumonia previously diagnosed within the past month, lung abscess diagnosed within the past six months, receipt of > 24 hours of beta-lactam antibiotic therapy already received at presentation to the ED, receipt of at least a 5 day course of amoxicillin < 72h prior to presenting to the ED, receipt of an intravenous cephalosporin or azithromycin in the ED, or suspected allergy to penicillin. Children will not be eligible to participate more than once.
研究组 & 干预措施
Short-course
Experimental
5 days amoxicillin 90 mg/kg/day divided TID followed by 5 days placebo TID
干预措施: Amoxicillin (Drug)
Short-course
Experimental
5 days amoxicillin 90 mg/kg/day divided TID followed by 5 days placebo TID
干预措施: Placebo (Drug)
Standard
Active Comparator
5 days amoxicillin 90 mg/kg/day divided TID followed by alternate formulation 5 days amoxicillin 90 mg/kg/day divided TID
干预措施: Amoxicillin (Drug)
结局指标
主要结局
Early clinical cure (Resolution of tachypnoea, increased work of breathing, and fever)
时间窗: at 14-21 days post-enrolment
Resolution of tachypnoea, increased work of breathing, and fever
次要结局
- Days of missed/disrupted work for caregiver(s)(up to 14 days post-enrolment)
- Days of adverse reactions(up to 14 days post-enrolment)
- Days of missed school(up to 14 days post-enrolment)
- Adherence to study medications(up to 10 days post-enrolment)
研究者
研究点 (2)
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