Status:
COMPLETED
Reduction of Intravenous Antibiotics In Neonates
Lead Sponsor:
Franciscus Gasthuis
Collaborating Sponsors:
Erasmus Medical Center
Conditions:
Neonatal Infection
Neonatal SEPSIS
Eligibility:
All Genders
1-28 years
Phase:
PHASE4
Brief Summary
Randomized controlled open-label non-inferiority trial comparing complete intravenous antibiotic treatment with a short iv. course followed by oral antibiotics in neonates (0-28 days) with probable ba...
Detailed Description
Neonates have a high antibiotic consumption because of their susceptibility for bacterial infections. Since the early diagnosis of bacterial infection in neonates is difficult, intravenous broad-spect...
Eligibility Criteria
Inclusion
- Neonates (≥ 35+0 weeks, 0-28 days old, ≥ 2 kg)
- Probable bacterial infection defined as clinical symptoms and/or maternal risk factors and elevated inflammatory markers for which empiric broad-spectrum antibiotic treatment was initiated and needs to be continued for \> 48 hours
- Clinically well
- Toleration of oral feeding without overt vomiting
- Signed informed consent
Exclusion
- Proven bloodstream infection
- Absence of blood culture
- Severe localized infection (meningitis, osteomyelitis, necrotizing enterocolitis)
- Severe clinical sepsis (compromised circulation, need for mechanical ventilation)
- Continuous need for a central venous line
- Severe hyperbilirubinemia exceeding the exchange level
- Parents inability to administer medication
- Major congenital or syndromic anomalies
Key Trial Info
Start Date :
November 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2021
Estimated Enrollment :
510 Patients enrolled
Trial Details
Trial ID
NCT03247920
Start Date
November 4 2017
End Date
July 15 2021
Last Update
August 24 2021
Active Locations (18)
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1
Meander Medical Center
Amersfoort, Netherlands
2
Rijnstate Hospital
Arnhem, Netherlands
3
Amphia Hospital
Breda, Netherlands
4
IJsselland Ziekenhuis
Capelle aan den IJssel, Netherlands