Critical severe infection (CSI) or critical illness of Possible Serious Bacterial Infection (PSBI) in sick young infants Infections and Infestations
Conditions
Interventions
Young infants (YIs) <2 months old visiting outpatient clinics or emergency rooms of participating hospitals will be screened for one low-mortality risk sign of CSI (study-1) or one high-mortality risk
Sponsors
World Health Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Study-1: 1. Aged <2 months 2. Living in a geographic area where follow-up for 14 days can be accomplished presenting to outpatient clinics or emergency rooms of participating hospitals 3. 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 (infants aged <7 days) Study-2: 1. Aged <2 months 2. 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 <35.5°C, two or more of the six signs of CSI) 3. 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 (<35.5°C, high body temperature (=38°C), severe chest indrawing, fast breathing in <7 days old) 4. Laboratory test negative 5. Family lives within a catchment area where a follow-up of up to day 15 can be accomplished
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 17/10/2022: Study-1: 1. Weight <2 kg at the time of presentation (if age at screening is less than 10 days) or weight for age <-3z 2. Appearance of low-mortality risk signs in first 24 h of life 3. Signs of critical illness (no movement at all, unable to feed at all, convulsions) 4. Signs of CSI associated with a high 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) 5. 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. 6. Hospitalized for any illness in the previous 2 weeks 7. Prior use of injectable antibiotics for the same illness in the last 2 days excluding pre-referral dose 8. Previously included in this study or currently included in any other study Study-2: 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 high-mortality risk sign or multiple low-mortality risk signs in first 24 h 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 hospital, as decided by the treating physician _____ Previous exclusion criteria: Study-1: 1. Weight <2 kg at the time of presentation (if age at screening is less than 10 days) or weight for age <-3z 2. Appearance of low-mortality risk signs in first 24 h of life 3. Signs of critical illness (no movement at all, unable to feed at all, convulsions) 4. Signs of CSI associated with a high 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) 5. 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. 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-2: 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 high-mortality risk sign or multiple low-mortality risk signs in first 24 h 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 hospital, as decided by the treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured using case report forms completed at follow up: Study-1: 1. Death any time from randomization up to day 15 of initiation of therapy 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, e.g. meningitis, bone or joint infection, on day 2, 4 or day 8 of initiation of therapy 3. Presence of any new sign of CSI on day 4 or day 8 of initiation of therapy 4. Persistence of the presenting sign on day 8 of the initiation of therapy Study-2: 1. Death between randomization (day 3 of initiation of therapy) and day 15 of initiation of therapy 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, e.g. meningitis, bone or joint infection, on day 8 of initiation of therapy 3. Presence of any sign of CSI on day 8 of initiation of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
India
Contacts
Public ContactYaswant Kumar Rao
Outcome results
None listed