Optimal place of treatment for young infants aged less than 2 months with any one low-mortality-risk sign of possible serious bacterial infectio

Not Applicable

Completed

Conditions: Treatment of low-mortality-risk signs of possible serious bacterial infection in young infants
Infections and Infestations
Possible serious bacterial infection

Registration Number: ISRCTN44033252

Lead Sponsor: World Health Organization

Brief Summary: 2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37449353/ (added 17/07/2023)

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 7002

Inclusion Criteria

1. Aged <2 months
2. Living in a geographic area where follow-up for 14 days can be accomplished
3. Presenting to outpatient clinics or emergency rooms of participating hospitals with 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 if aged <7 days

Exclusion Criteria

1. Weight for age <-3 z, or weight <2 kg at the time of presentation if age at screening is less than 10 days
2. Signs of critical illness (no movement at all, unable to feed at all, or convulsions)
3. Signs of clinical severe infection (CSI) associated with a moderate 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)
4. Any sign suggestive of another serious illness/condition, such as but not limited to: major congenital malformations, severe jaundice, conditions requiring major surgery, meningitis, bone or joint infection, or severe dehydration
5. Appearance of low-mortality risk signs in the first 24 h of life
6. Hospitalized for any illness in the previous 2 weeks
7. Prior use of injectable antibiotics for the same illness
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
1. Poor clinical outcome defined as any one of the following:<br>1.1. Death any time between baseline and 15 days<br>1.2. Presence of any sign of critical illness (no movement at all, unable to feed at all, or convulsions) or any sign suggestive of another serious infection (such as meningitis, or bone and joint infection) at 2, 4, and 8 days<br>1.3. Presence of any new sign of clinical severe infection (CSI) at 4 and 8 days <br>1.4. Persistence of the presenting sign at 8 days

Secondary Outcome Measures