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Clinical Trials/CTRI/2020/12/029776
CTRI/2020/12/029776
Recruiting
未知

Optimizing place of treatment for young infants presenting with any low mortality risk sign of possible serious bacterial infection-Study 1 - PSBI RCT 1

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: A499- Bacterial infection, unspecified
Sponsor
Centre for Health Research and Development Society for Applied Studies
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • All young infants \< 2months days old, living in a geographic area where follow\-up for 14 days can be accomplished presenting to outpatient clinics or emergency rooms of participating hospitals will considered for inclusion in this study if they have ONLY one of the following low\-risk signs of PSBI:
  • 1\. Body temperature \>\=38°C, or
  • 2\. Severe chest indrawing, or
  • 3\. Fast breathing ( \<7 days old infants).

Exclusion Criteria

  • 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 (no movement at all, unable to feed at all, convulsions), or
  • 3\.Signs of CSI associated with a high risk of mortality (stopped feeding well, movement only on stimulation, low body temperature \< 35\.5oC or two or more of the six signs of CSI), or
  • 4\. Any sign suggestive of another serious illness/condition, such as major congenital malformations, severe jaundice, conditions requiring major surgery, meningitis, bone or joint infection, severe dehydration, etc., or
  • 5\. Appearance of low\-mortality risk signs in first 24 hours of life , or
  • 6\. Hospitalized for any illness in the previous 2 weeks, or
  • 7\. Prior use of injectable antibiotics for the same illness, or
  • 8\. Previously included in this study or currently included in any other study

Outcomes

Primary Outcomes

Not specified

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