ISRCTN11693277
Active, not recruiting
未知
Optimizing place of treatment and antibiotic regimens for young infants presenting with signs of possible serious bacterial infection
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Critical severe infection (CSI) or critical illness of Possible Serious Bacterial Infection (PSBI) in sick young infants
- Sponsor
- World Health Organization
- Enrollment
- 12250
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Aged \<2 months
- •2\. Living in a geographic area where follow\-up for 14 days can be accomplished presenting to outpatient clinics or emergency rooms of participating hospitals
- •3\. 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 (infants aged \<7 days)
- •1\. Aged \<2 months
- •2\. 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\.5°C, two or more of the six signs of CSI)
- •3\. 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\.5°C, high body temperature (\=38°C), severe chest indrawing, fast breathing in \<7 days old)
- •4\. Laboratory test negative
Exclusion Criteria
- •Current exclusion criteria as of 17/10/2022:
- •1\. Weight \<2 kg at the time of presentation (if age at screening is less than 10 days) or weight for age \<\-3z
- •2\. Appearance of low\-mortality risk signs in first 24 h of life
- •3\. Signs of critical illness (no movement at all, unable to feed at all, convulsions)
- •4\. Signs of CSI associated with a high 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)
- •5\. 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.
- •6\. Hospitalized for any illness in the previous 2 weeks
- •7\. Prior use of injectable antibiotics for the same illness in the last 2 days excluding pre\-referral dose
- •8\. Previously included in this study or currently included in any other study
- •1\. Weight \<2 kg at the time of presentation (if age at screening is less than 10 days) or weight\-for\-age \<\-3z
Outcomes
Primary Outcomes
Not specified
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