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

Not Applicable

Conditions: Health Condition 1: A499- Bacterial infection, unspecified

Registration Number: CTRI/2020/12/029776

Lead Sponsor: Centre for Health Research and Development Society for Applied Studies

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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 >=38Â°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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death <br/ ><br>Presence of any sign of critical illness or sign suggestive of another serious infection <br/ ><br>Presence of any new sign of CSI <br/ ><br>Persistence of presenting sign <br/ ><br>Timepoint: Day 1-15 <br/ ><br>Days 2, 4, 8 <br/ ><br>Days 4, 8, <br/ ><br>Day 8

Secondary Outcome Measures