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

World Health Organization0 sites5,250 target enrollmentJanuary 20, 2021

Overview

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37448340/ (added 17/07/2023)

Registry

who.int

Start Date

January 20, 2021

End Date

December 31, 2024

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•All patients (\<2 months old at admission) admitted to the study hospitals with any moderate\-mortality risk signs of clinical severe infection (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) 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 the 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)
•2\. C\-reactive protein (CRP) test negative
•3\. Family lives within a catchment area where a follow\-up of up to day 15 can be accomplished

•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 moderate\-mortality risk sign or multiple low\-mortality risk signs in the first 24 hours 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 the hospital, as decided by the treating physician