ISRCTN95821329已完成不适用
Multicentre prospective randomised clinical trial to compare the safety and efficacy of outpatient treatment with oral amoxicillin with that of injectable ampicillin in children aged 3 to 59 months: APPIS II Randomised Controlled Trial (RCT), Pakista
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)0 个研究点目标入组 2,100 人开始时间: 2006年3月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Children aged 3 to 59 months with severe pneumonia. Severe pneumonia is defined as Lower Chest Indrawing (LCI) in children with cough and/or difficult breathing, who are able to drink and do not have central cyanosis, regardless of the respiratory rate
- •2. Known Human Immunodeficiency Virus (HIV) infected patients in clinical category N or A (Centers for Disease Control [CDC]) will be included
- •3. Informed consent by a legal guardian
排除标准
- •Children with any of the following conditions will be excluded:
- •1. Very severe pneumonia/disease
- •2. Known prior episodes of asthma or three or more prior episodes of wheezing
- •3. LCI that resolves after three doses of bronchodilator therapy
- •4. Severe malnutrition (visible severe wasting or oedema)
- •5. Known anaphylactic reaction to penicillin or amoxicillin
- •6. Hospitalisation in the last two weeks
- •7. Other diseases requiring antibiotic therapy at presentation, such as meningitis, dysentery, osteomyelitis, septic arthritis, evident tuberculosis etc.
- •8. Persistent vomiting
- •9. Previous inclusion in the study
- •10. Living outside a pre-defined area
- •11. Parental or caretaker refusal to participate in the study
研究者
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