Treatment of low-mortality-risk signs of possible serious bacterial infection in young infants Infections and Infestations Possible serious bacterial infection
Conditions
Interventions
Eligible participants will be randomised (1:1) to either intervention or control groups. A WHO statistician not otherwise associated with study implementation will generate a randomization scheme with
Sponsors
World Health Organization
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Poor clinical outcome defined as any one of the following: 1.1. Death any time between baseline and 15 days 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 1.3. Presence of any new sign of clinical severe infection (CSI) at 4 and 8 days 1.4. Persistence of the presenting sign at 8 days | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
Bangladesh, Ethiopia, India, Nigeria, Pakistan, Switzerland, Tanzania, United States of America
Contacts
Public ContactYasir Bin Nisar
Outcome results
None listed