Neonatal probable bacterial infection
Conditions
Interventions
Product Name: amoxicillin/clavulanic acid
Pharmaceutical Form: Syrup
INN or Proposed INN: AMOXICILLIN
CAS Number: 26787-78-0
Other descriptive name: amoxicilline
INN or Proposed INN: CLAVULANIC ACID
C
Sponsors
Stichting Rotterdams Onderzoeksconsortium Kindergeneeskunde
Eligibility
Sex/Gender
All
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 PCT according to age-related normogram and/or elevated CRP)) for which empiric broad-spectrum antimicrobial treatment was initiated and need 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 Are the trial subjects under 18? yes Number of subjects for this age range: 600 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • proven bloodstream infection, failed blood culture • severe localized infection such as meningitis, osteomyelitis, necrotizing enterocolitis (pneumonia and urinary tract infection excluded) • severe clinical sepsis on admission (compromised circulation; need for mechanical ventilation) • known colonization with resistant bacteria such as MRSA, ESBL-producing bacteria • continuous need for central venous line (umbilical venous catheter, PICC) • 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 |
|---|---|
| Main Objective: To demonstrate the non-inferiority of intravenous-to-oral antibiotic switch therapy in clinically stable neonates with probable bacterial infection compared to a complete course of intravenous antibiotic therapy;Secondary Objective: • To describe the pharmacokinetics of oral amoxicillin/clavulanic acid in neonates • To quantify the cost-effectiveness of oral antimicrobial switch therapy in neonates • To study antimicrobial resistance and modification of the gut microbiome in relation to type and delivery of antibiotics. ;Primary end point(s): 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)).;Timepoint(s) of evaluation of this end point: 28 days after finishing treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • 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 at day 7, 14, 21, 28, 35 (painful procedures; breastfeeding; sleep quality; gastro-intestinal symptoms; parental satisfaction) • nosocomial infections • gut microbial flora profile and antimicrobial resistance genes ;Timepoint(s) of evaluation of this end point: 28 days | — |
Countries
Netherlands
Contacts
Public ContactNico Hartwig
Stichting ROCK
Outcome results
None listed