Overview

Reduction of Intravenous Antibiotics In Neonates

Status:
Completed
Trial end date:
2021-07-15
Target enrollment:
Participant gender:
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 bacterial infection. Primary outcome: - Bacterial re-infection within 28 days after finishing of antibacterial therapy. Secondary outcome(s): - Pharmacokinetic profile of oral amoxicillin/clavulanic acid - Quality of life - Cost-effectiveness - Alterations in gut microbiome - Use of molecular techniques for better detection of bacterial pathogens
Phase:
Phase 4
Details
Lead Sponsor:
Franciscus Gasthuis
Collaborator:
Erasmus Medical Center
Treatments:
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Antibiotics, Antitubercular
Clavulanic Acid
Clavulanic Acids