CTRI/2020/11/029309
Completed
未知
Optimizing place of treatment and antibiotic regimens for young infants presenting with signs of possible serious bacterial infection - PSBI
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: A30-A49- Other bacterial diseases
- Sponsor
- World Health Organization
- Enrollment
- 1961
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Study\-1: All young infants \<2 months old, living in the study area where follow\-up for 14 days can be accomplished presenting to outpatient clinics or emergency rooms of participating hospitals will be considered for inclusion in this study if they have ONLY one of the following low\-risk signs of PSBI:
- •\- Body temperature \= 38°C, or
- •\- Severe chest indrawing, or
- •\- Fast breathing ( \<7 days old infants only).
- •2\) Study\-2: All young infants \<2 months old, living in the study area where follow\-up for 14 days can be accomplished, and 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:
- •\- 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
- •\- Laboratory test negative
Exclusion Criteria
- •1\) Study\-1: The Young Infant will be excluded if they have any of the following:
- •\- Weight \<2kg at the time of presentation (if age at screening is less than 10 days) or weight for age \<\-3z, or
- •\- Appearance of low\-mortality risk signs in first 24 hours of life, or
- •\- Signs of critical illness (no movement at all, unable to feed at all, convulsions), or
- •\- 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
- •\- 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
- •\- Hospitalized for any illness in the previous 2 weeks, or
- •\- Prior use of injectable antibiotics for the same illness, or
- •\- Previously included in this study or currently included in any other study.
- •2\) Study\-2: The Young Infant will be excluded if they have any of the following:
Outcomes
Primary Outcomes
Not specified
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