Treatment of moderate-mortality-risk signs of possible serious bacterial infection in young infants <2 months old Infections and Infestations
Conditions
Interventions
Young infants <2 months of age with moderate mortality risk signs of possible serious bacterial infection (low body temperature [<35.5°C], not feeding well/stopped feeding well, movement only when sti
Sponsors
World Health Organization
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Poor clinical outcome defined as: 1. Death between randomization (day 3 of initiation of therapy) and day 15 of initiation of therapy, or 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 4 or day 8 of initiation of therapy, or 3. Presence of any sign of clinical severe infection (severe chest indrawing, high body temperature (>38°C), low body temperature [60 breaths/minute in <7 days old]) or two or more of clinical severe infection signs on day 8 of initiation of therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
Bangladesh, Ethiopia, India, Nigeria, Pakistan, Tanzania
Contacts
Public ContactYasir Bin Nisar
Outcome results
None listed