neonatal infection
Conditions
Interventions
After informed consent has been obtained, the neonate will be allocated by a
web-based randomisation tool to:
1. continue intravenous antimicrobial therapy (broad-spectrum, preferably
according to
Sponsors
Sint Franciscus Gasthuis
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: Neonates, * 35+0 weeks of gestation, 0-28 days old, * 2.0 kg. ;* probable bacterial infection (clinical symptoms and/or maternal risk factors and elevated inflammatory parameters (elevated CRP and/or elevated PCT according to age-related normogram7) for which empiric broad-spectrum antimicrobial treatment was initiated and needs to be continued for > 48 hours at the discretion of the treating physician * reassuring level and trends of inflammatory parameters 48-72 hours after initiation of antimicrobial treatment * clinically stable * tolerates oral feeding and/or liquids without overt vomiting * written informed consent of parents or legal representatives;For the specific PK-study, neonates also can participate when they fulfill the inclusion criteria and are given oral amoxicillin/clavulanic acid not for this specific trial but for another reason.
Exclusion criteria
Exclusion criteria: * proven bloodstream infection * absence of blood culture (i.e. no blood culture taken) * severe localized infection such as meningitis, osteomyelitis, necrotizing enterocolitis (except pneumonia and urinary tract infection) * severe clinical sepsis on admission (compromised circulation; need for mechanical ventilation) * known (maternal) colonization with resistant bacteria such as MRSA, ESBL-producing bacteria * continuous need for central venous line (umbilical venous catheter, PICC) * severe hyperbilirubinaemia with need for phototherapy * clinicians* decision to continue with intravenous antibiotics because of other reasons * parents* inability to administer medication because of social reasons or language difficulties
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bacterial (re)-infection within 28 days after finishing of antimicrobial therapy ((defined as clinical signs and symptoms of bacterial infection and fever (> 38.0 deg C) or undertemperature ( 48 h) antibiotic treatment)). | — |
Secondary
| Measure | Time frame |
|---|---|
| * duration of hospitalization * percentage re-admission * total costs and cost-effectiveness * clinical side effects of antibiotics * pharmacokinetic profile of oral amoxicillin * pharmacokinetic profile of oral clavulanic acid * quality of life (painful procedures; breastfeeding; sleep quality; gastro-intestinal symptoms; parental satisfaction) * nosocomial infections * gut microbial flora profile and antimicrobial resistance genes | — |
Countries
Netherlands
Outcome results
None listed