Clinical definition:
Sepsis in the newborn is defined as the invasion of the blood by bacteria or other microorganisms before or after birth which may spread to involve other organs/systems e.g. meninges (meningitis), lungs (pneumonia), bone (osteomyelitis) and kidneys (pyelonephritis). Symptoms may be variable and non-specific.
Common bacterial pathogens that can cause sepsis in the newborn include Group B streptococcus, S. aureus, Enterococcus species, Gram-negative organisms including Enterobacteriaceae (such as E. coli, K. pneumoniae, Enterobacter and Serratia species) and Acinetobacter species and Pseudomonas species. The latter two are more commonly hospital associated, and will vary depending on local hospital settings. L. monocytogenes, although a recognised neonatal pathogen, is less common.
Early-onset (Less than 48 hours of age) | |||
| Preferred antibiotic choice | |||
| Drug | Formulation | Dosage | Duration |
| Combination therapy with: Ampicillin (IV) PLUS Gentamicin (IV)A | Ampicillin- Powder for injection: 500 mg; 1 g (as sodium salt) in vial | o First week of life (7 days or less): 50 mg/kg/dose 8 hourly o 8 days of age & older: 50 mg/kg/dose 6 hourly | 5 – 7 days or as determined by clinical assessment and laboratory / microbiological results |
| Gentamicin- Injection: 10 mg; 40 mg (as sulfate)/ mL in 2- mL vial. | o 4 mg/kg/dose once daily | ||
| For patients not responding to therapy | |||
| 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 | 5 – 7 days or as determined by clinical assessment and laboratory / microbiological results |
| Ampicillin- Powder for injection: 500 mg, 1 g (as sodium salt) in vial | o First week of life (7 days or less): 50 mg/kg/dose 8 hourly o 8 days of age & older: 50 mg/kg/dose 6 hourly | ||
Late-onset (48 hours of age & older ) | |||
| Preferred antibiotic choice | |||
| Drug | Formulation | Dosage | Duration |
| 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 | 5 – 7 days or as determined by clinical assessment and laboratory / microbiological results |
| Ampicillin- Powder for injection: 500 mg, 1 g (as sodium salt) in vial | o First week of life (7 days or less): 50 mg/kg/dose 8 hourly o 8 days of age & older: 50 mg/kg/dose 6 hourly | ||
| For patients not responding to therapy or guided by laboratory/microbiological results or in health care facilities with high rates of hospital-acquired multidrug resistant gram-negative pathogens | |||
| If meningitis suspected or confirmed: Meropenem (IV)
If meningitis excluded or considered unlikely: Piperacillin/tazobactam (IV) PLUS Amikacin (IV)A
| Meropenem- Powder for injection: 500 mg (as trihydrate); 1 g (as trihydrate) in vial | 40 mg/kg/dose 8 hourly | If meningitis is confirmed: 14 –21 days |
| Piperacillin/tazobactam- Powder for injection: 2 g (as sodium salt) + 250 mg (as sodium salt); 4 g (as sodium salt) + 500 mg (as sodium salt) in vial | o First week of life (7 days or less): 100 mg/kg/dose 12 hourly o 8 days of age & older: 100 mg/kg/dose 8 hourly | 7 – 10 days | |
| Amikacin- Powder for injection: 100 mg; 500 mg; 1 g (as sulfate) in vial. | 15 mg/kg/dose once daily | ||
A. When treating with gentamicin or amikacin, conduct renal function testing and therapeutic drug monitoring, where available.
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.
Principles of Stewardship:
- Empirical antibiotic selection should be guided by local patterns of antibiotic susceptibility, where data is available. In the absence of local data, follow the above-described guidelines.
- If an organism is cultured and antibiotic susceptibility testing is available, switching to a narrower spectrum antibiotic should be considered in discussion with a specialist and/or clinical microbiologist.
- Therapy duration should be determined by clinical and laboratory results and clinical response.
Notes:
- Consider the addition of vancomycin in patients not responding to treatment or if resistant staphylococcal infection is suspected.