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Clinical Trials/CTRI/2020/12/029623
CTRI/2020/12/029623
Recruiting
未知

Optimizing duration of hospitalization for young infants presenting with any moderate mortality risk sign of possible serious bacterial infection-Study 2 - PSBI RCT 2

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 patients admitted to the study hospitals with relatively higher\-mortality risk signs of CSI at presentation (not feeding well, movement only on stimulation, low body temperature \< 35\.5oC, 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 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\.5oC), high body temperature (\>\=38oC), severe chest indrawing, fast breathing in \<7 days old), and
  • 2\. Laboratory test negative, and
  • 3\. Family lives within a catchment area where a follow\-up of up to day 15 can be accomplished.

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 on admission (no movement at all, unable to feed at all, or convulsions), or
  • 3\. Appearance of any high\-mortality risk sign or multiple low\-mortality risk signs in first 24 hours of life, or
  • 4\. Hospitalized for any illness in the previous 2 weeks, or
  • 5\. Prior use of injectable antibiotics for the same illness, or
  • 6\. Previously included in this study or currently included in any other study, or
  • 7\. Any other reason to stay in hospital, as decided by the treating physician

Outcomes

Primary Outcomes

Not specified

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