ISRCTN11693277进行中（未招募）未知
Optimizing place of treatment and antibiotic regimens for young infants presenting with signs of possible serious bacterial infection
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 12,250
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. Aged <2 months
- •2. Living in a geographic area where follow-up for 14 days can be accomplished presenting to outpatient clinics or emergency rooms of participating hospitals
- •3. 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 (infants aged <7 days)
- •1. Aged <2 months
- •2. Admitted to the study hospitals with relatively higher-mortality risk signs of CSI at presentation (not feeding well, movement only on stimulation, low body temperature <35.5°C, two or more of the six signs of CSI)
- •3. Clinically well on day 3 defined as absence of all signs of critical illness (not feeding at all, no movement at all, convulsions) or CSI (not feeding well, movement only when stimulated, low body temperature (<35.5°C, high body temperature (=38°C), severe chest indrawing, fast breathing in <7 days old)
- •4. Laboratory test negative
- •5. Family lives within a catchment area where a follow-up of up to day 15 can be accomplished
排除标准
- •Current exclusion criteria as of 17/10/2022:
- •1. Weight <2 kg at the time of presentation (if age at screening is less than 10 days) or weight for age <-3z
- •2. Appearance of low-mortality risk signs in first 24 h of life
- •3. Signs of critical illness (no movement at all, unable to feed at all, convulsions)
- •4. Signs of CSI associated with a high 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)
- •5. Any sign suggestive of another serious illness/condition, such as major congenital malformations, severe jaundice, conditions requiring major surgery, meningitis, bone or joint infection, severe dehydration, etc.
- •6. Hospitalized for any illness in the previous 2 weeks
- •7. Prior use of injectable antibiotics for the same illness in the last 2 days excluding pre-referral dose
- •8. Previously included in this study or currently included in any other study
- •1. Weight <2 kg at the time of presentation (if age at screening is less than 10 days) or weight-for-age <-3z
- •2. Signs of critical illness on admission (no movement at all, unable to feed at all, or convulsions)
- •3. Appearance of any high-mortality risk sign or multiple low-mortality risk signs in first 24 h of life
- •4. Hospitalized for any illness in the previous 2 weeks
- •5. Prior use of injectable antibiotics for the same illness
- •6. Previously included in this study or currently included in any other study
- •7. Any other reason to stay in hospital, as decided by the treating physician
- •Previous exclusion criteria:
- •1. Weight <2 kg at the time of presentation (if age at screening is less than 10 days) or weight for age <-3z
- •2. Appearance of low-mortality risk signs in first 24 h of life
- •3. Signs of critical illness (no movement at all, unable to feed at all, convulsions)
- •4. Signs of CSI associated with a high 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)
- •5. Any sign suggestive of another serious illness/condition, such as major congenital malformations, severe jaundice, conditions requiring major surgery, meningitis, bone or joint infection, severe dehydration, etc.
- •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
- •1. Weight <2 kg at the time of presentation (if age at screening is less than 10 days) or weight-for-age <-3z
- •2. Signs of critical illness on admission (no movement at all, unable to feed at all, or convulsions)
- •3. Appearance of any high-mortality risk sign or multiple low-mortality risk signs in first 24 h of life
- •4. Hospitalized for any illness in the previous 2 weeks
- •5. Prior use of injectable antibiotics for the same illness
- •6. Previously included in this study or currently included in any other study
- •7. Any other reason to stay in hospital, as decided by the treating physician
研究者
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