NCT01200706已完成4 期
Clinical Efficacy of Amoxicillin Given Twice or Three Times a Day Among Children With Non-severe Community-acquired Pneumonia
Federal University of Bahia1 个研究点 分布在 1 个国家目标入组 820 人开始时间: 2006年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 820
- 试验地点
- 1
- 主要终点
- clinical efficacy
研究概览
简要总结
The purpose of the study is to compare the clinical efficacy of amoxicillin given twice or three times a day to children with non-severe 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
- 2 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged between 2 and 59 months
- •Report of respiratory complaints
- •Presence of pulmonary infiltrate on chest x-ray taken on admission and read by the pediatrician on duty
排除标准
- •lower chest indrawing
- •danger signs (inability to drink, convulsions, somnolence, central cyanosis, grunting in a calm child)
- •diagnosed underlying chronic diseases (anatomic abnormalities of the respiratory tract, chronic pulmonary illness besides asthma, immunological defects, progressing neurological disorders, psychomotor retardation, heart disease with clinical repercussion, hemoglobinopathy, liver or kidney disease)
- •severe malnutrition
- •other concurrent infection
- •hospitalization during the previous 7 days
- •amoxicillin or similar antibiotic use during the last 48 hours
- •allergy to amoxicillin
- •history of aspiration
研究组 & 干预措施
Amoxicillin given twice a day
Active Comparator
干预措施: Amoxicillin (Drug)
Amoxicillin given three times a day
Active Comparator
干预措施: Amoxicillin (Drug)
结局指标
主要结局
clinical efficacy
时间窗: 48 hours
resolution of fever, difficulty breathing and tachypnea
次要结局
- Resolution of cough(96 hours)
研究者
研究点 (1)
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