Optimizing duration of hospitalization for young infants presenting with any moderate mortality risk sign of possible serious bacterial infection-Study 2 - PSBI RCT 2

Centre for Health Research and Development Society for Applied Studies0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年7月25日

试验速览

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•All patients 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 < 35.5oC, two or more of the six signs of CSI) will be assessed for eligibility for this study 48 hours after initiation of treatment and considered for inclusion in the study if:
•1. 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 ( <35.5oC), high body temperature (>=38oC), severe chest indrawing, fast breathing in <7 days old), and
•2. Laboratory test negative, and
•3. Family lives within a catchment area where a follow-up of up to day 15 can be accomplished.

•1. Weight <2kg at the time of presentation (if age at screening is less than 10 days) or weight-for-age <-3z, or
•2. Signs of critical illness on admission (no movement at all, unable to feed at all, or convulsions), or
•3. Appearance of any high-mortality risk sign or multiple low-mortality risk signs in first 24 hours of life, or
•4. Hospitalized for any illness in the previous 2 weeks, or
•5. Prior use of injectable antibiotics for the same illness, or
•6. Previously included in this study or currently included in any other study, or
•7. Any other reason to stay in hospital, as decided by the treating physician

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