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Clinical Trials/ISRCTN44033252
ISRCTN44033252
Completed
未知

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

World Health Organization0 sites7,002 target enrollmentJanuary 20, 2021

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)

Registry
who.int
Start Date
January 20, 2021
End Date
May 15, 2024
Last Updated
last year
Study Type
Interventional
Sex
All

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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