ISRCTN44033252已完成未知
Optimizing place of treatment for young infants presenting with any low-mortality-risk sign of possible serious bacterial infection.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 7,002
研究概览
简要总结
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37449353/ (added 17/07/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged <2 months
- •2. Living in a geographic area where follow-up for 14 days can be accomplished
- •3. Presenting to outpatient clinics or emergency rooms of participating hospitals with only one of the following low-risk signs of PSBI:
- •3.1. Body temperature =38°C
- •3.2. Severe chest indrawing
- •3.3. Fast breathing if aged <7 days
排除标准
- •1. Weight for age <-3 z, or weight <2 kg at the time of presentation if age at screening is less than 10 days
- •2. Signs of critical illness (no movement at all, unable to feed at all, or convulsions)
- •3. Signs of clinical severe infection (CSI) associated with a moderate risk of mortality (stopped feeding well, movement only on stimulation, low body temperature <35.5°C, or two or more of the six signs of CSI)
- •4. Any sign suggestive of another serious illness/condition, such as but not limited to: major congenital malformations, severe jaundice, conditions requiring major surgery, meningitis, bone or joint infection, or severe dehydration
- •5. Appearance of low-mortality risk signs in the first 24 h of life
- •6. Hospitalized for any illness in the previous 2 weeks
- •7. Prior use of injectable antibiotics for the same illness
- •8. Previously included in this study or currently included in any other study
研究者
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