Optimizing place of treatment for young infants presenting with any low-mortality-risk sign of possible serious bacterial infection.

World Health Organization0 个研究点目标入组 7,002 人开始时间: 2021年1月20日最近更新: 2024年6月18日

适应症

试验速览

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37449353/ (added 17/07/2023)

•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

•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

发起方