How long should young infants less than 2 months of age with moderate-mortality-risk signs of possible serious bacterial infection be hospitalized for?

Not Applicable

• Conditions: Treatment of moderate-mortality-risk signs of possible serious bacterial infection in young infants <2 months old; Infections and Infestations

• Registration Number: ISRCTN16872570
• Lead Sponsor: World Health Organization

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37448340/ (added 17/07/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-20
• Last Update Posted: 3 June 2024
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 5250

Inclusion Criteria

All patients (<2 months old at admission) admitted to the study hospitals with any moderate-mortality risk signs of clinical severe infection (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) 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 the 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)
2. C-reactive protein (CRP) test negative
3. Family lives within a catchment area where a follow-up of up to day 15 can be accomplished

Exclusion Criteria

1. Weight <2 kg at the time of presentation (if age at screening is less than 10 days) or weight-for-age <-3z
2. Signs of critical illness on admission (no movement at all, unable to feed at all, or convulsions)
3. Appearance of any moderate-mortality risk sign or multiple low-mortality risk signs in the first 24 hours of life
4. Hospitalized for any illness in the previous 2 weeks
5. Prior use of injectable antibiotics for the same illness
6. Previously included in this study or currently included in any other study
7. Any other reason to stay in the hospital, as decided by the treating physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified