Optimizing duration of hospitalization for young infants with sepsis

Not Applicable

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

Registration Number: CTRI/2020/12/029623

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 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

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 <br/ ><br>suggestive of another serious infection <br/ ><br>Presence of any sign of CSITimepoint: Randomization to Day 15 <br/ ><br>Day 8 <br/ ><br> <br/ ><br>Day 8 <br/ ><br>

Secondary Outcome Measures