PACTR202106720981298尚未招募3 期
Supportive Care and Antibiotics for Severe Pneumonia among Hospitalised Children (SEARCH): A Pragmatic Randomised Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 4,392
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
- 年龄范围
- 1 Month(s) 至 23 Month(s)(—)
- 性别
- All
入选标准
- •Age 2 to 59 months.
- •History of cough or difficulty breathing and signs of severe pneumonia based on WHO 2013 criteria
- •Admitted to any one of the study hospitals.
- •Informed consent provided by the parents/guardian.
排除标准
- •Children presenting in cardiorespiratory arrest requiring emergency basic life support (bag-valve-mask ventilation and/or chest compressions).
- •Children for whom concurrent condition precludes the use of the first-line antibiotics for severe pneumonia such as readmission or meningitis
- •Shock due to dehydration or severe dehydration (based on WHO definitions (5)) requiring emergency fluid resuscitation
- •Known allergy or contraindication to penicillin, gentamicin, ceftriaxone or amoxicillin-clavulanic acid.
- •Referral from another inpatient facility following treatment with injectable antibiotics for more than 24 hours or because the first-line regimen is considered to have failed
- •Previously enrolled in the study.
- •For Randomisation 2 (IV fluid versus nasogastric feeds): children with absent gag reflex.
- •For Randomisation 2 (IV fluid versus nasogastric feeds): children unable to maintain oxygen saturations ?90% on pulse oximetry while receiving supplemental oxygen.
- •For Randomisation 2 (IV fluid versus nasogastric feeds): children with severe acute malnutrition
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