Clinical definition:
An acutely unwell neonate or young infant for whom an urgent diagnostic assessment for possible serious bacterial infection including meningitis, pneumonia, urinary tract infection and bloodstream infection is required, and urgent empirical broad-spectrum antibiotic treatment is appropriate. In infants older than 3 months of age, children and adolescents, the choice of empiric antibiotic therapy should be guided by the clinical presentation and directed at the most likely organ system(s) involved and guided by the relevant section in this guideline. If the clinical presentation is non-specific, use the empiric antibiotic recommendations for the infant (28 – 90 days of age) below.
Neonate | |||
| Preferred antibiotic choice | |||
| Drug | Formulation | Dosage | DurationA |
| Combination therapy with: Cefotaxime (IV)B PLUS Ampicillin (IV) | Cefotaxime- Powder for injection: 250 or 500 mg per vial (as sodium salt) | o First week of life (7 days or less): 50 mg/kg/dose 12 hourly o 8-20 days: 50 mg/kg/dose 8 hourly o 21 days & older: 50 mg/kg/dose 6 hourly | 7 – 10 days |
| Ampicillin- Powder for injection: 500 mg, 1 g (as sodium salt) in vial | o First week of life (7 days or less): 100 mg/kg/dose 8 hourly o 8 days of age & older: 100 mg/kg/dose 6 hourly | ||
| If meningitis excluded or considered unlikely | |||
| Combination therapy with: Ampicillin (IV) PLUS Cloxacillin (IV) PLUS Gentamicin (IV) | Ampicillin- Powder for injection: 500 mg, 1 g (as sodium salt) in vial | o First week of life (7 days or less): 100 mg/kg/dose 8 hourly o 8 days of age & older: 100 mg/kg/dose 6 hourly | 7 – 10 days |
| Cloxacillin- Powder for injection: 500 mg (as sodium salt) in vial. | o First week of life (7 days or less): 50 mg/kg/dose 12 hourly o 8-28 days: 50 mg/kg/dose 8 hourly o Older than 28 days: 50 mg/kg/dose 6 hourly | ||
| Gentamicin- Injection: 10 mg; 40 mg (as sulfate)/ mL in 2- mL vial. | o 4 mg/kg/dose once daily | ||
| If Cloxacillin (IV) is not available, substitute with:
Cefazolin (IV)
Treat in combination with Ampicillin (IV) and Gentamicin (IV), as above. | Cefazolin- Powder for injection: 1 g (as sodium salt) in vial. | o First week of life (7 days or less): 50 mg/kg/dose 12 hourly o 8 days of age & older: 50 mg/kg/dose 8 hourly | |
Infant | |||
| Preferred antibiotic choice | |||
| Drug | Formulation | Dosage | DurationA |
| Ceftriaxone (IV) | Powder for injection: 250 mg; 1 g (as sodium salt) in vial | 50 mg/kg/dose 12 hourly | 7 – 10 days |
| If meningitis excluded or considered unlikely | |||
| Combination therapy with: Ampicillin (IV) PLUS Cloxacillin (IV) PLUS Gentamicin (IV)C | Ampicillin- Powder for injection: 500 mg, 1 g (as sodium salt) in vial | 50 mg/kg/dose 6 hourly | 7 – 10 days |
| Cloxacillin- Powder for injection: 500 mg (as sodium salt) in vial. | 50 mg/kg/dose 6 hourly | ||
| Gentamicin- Injection: 10 mg; 40 mg (as sulfate)/ mL in 2- mL vial. | 5-7.5 mg/kg once daily
| ||
A. The duration of antibiotic therapy depends on whether a focus of bacterial infection is confirmed (e.g. meningitis, lower respiratory tract infection, UTI, osteomyelitis / septic arthritis, bloodstream infection) and clinical response to treatment. Refer to the relevant sections on specific infections in this guideline. If no focus of infection is apparent clinically or confirmed on laboratory / microbiological testing, continue IV antibiotics until there is a good clinical response and laboratory markers of infection improve (usually less than one week)
B. If cefotaxime is not available, use ceftriaxone 50 mg/kg/dose 12 hourly in neonates (in combination with benzylpenicillin or ampicillin) except in neonates with jaundice and neonates receiving calcium-containing IV fluids.
C. When treating with gentamicin, conduct renal function testing and therapeutic drug monitoring, where available.
Principles of Stewardship:
- Reconsider choice of antibiotic, aiming for monotherapy where possible, when the results of cultures and antibiotic susceptibility testing become available or if the child does not improve.
Notes:
- Early administration of broad-spectrum antibiotics is critical in patients presenting with sepsis.