ISRCTN44033252
Completed
未知
Optimizing place of treatment for young infants presenting with any low-mortality-risk sign of possible serious bacterial infection.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Treatment of low-mortality-risk signs of possible serious bacterial infection in young infants
- Sponsor
- World Health Organization
- Enrollment
- 7002
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37449353/ (added 17/07/2023)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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