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Oral Switch in Pediatric Bloodstream Infections
Sponsor: Ulrikka Nygaard
Summary
This nationwide, multicenter, randomized, non-inferiority trial of children and adolescents with uncomplicated bloodstream infections aims to investigate if early-oral antibiotic switch (experimental arm) is non-inferior to standard intravenous antibiotics (control arm) with respect to treatment failure.
Official title: Early Oral Switch Versus Intravenous Antibiotics in Previously Healthy Children and Adolescents With Bloodstream Infections
Key Details
Gender
All
Age Range
4 Weeks - 17 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-09-01
Completion Date
2029-11-01
Last Updated
2026-10-19
Healthy Volunteers
No
Conditions
Interventions
Oral antibiotic therapy
Participants randomised to the experimental arm will switch to oral antibiotic therapy as soon as possible after clinical stability and within 4 days after initiation of effective IV antibiotic therapy. Children who have not received antibiotics, or who have received oral antibiotics before the blood culture becomes positive, may also be randomised; thus, prior IV therapy is not required in the experimental arm.
Standard IV antibiotic therapy
Participants allocated to the control group will continue IV therapy for at least 5 days after initiation of effective IV antibiotic therapy, with 7 days recommended, followed by oral step-down if appropriate.
Locations (18)
Department of Pediatrics, Aabenraa Hospital
Aabenraa, Denmark
Department of Pediatrics, Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark
Department of Pediatrics, Esbjerg Hospital
Esbjerg, Denmark
Department of Paediatrics and adolescent medicine, NIDO Danmark, Gødstrup Hospital
Gødstrup, Denmark
Department of Pediatrics, Herlev Hospital
Herlev, Denmark
Department of Pediatrics, Hillerød Hospital
Hillerød, Denmark
Department of Pediatrics, Hjørring Hospital
Hjørring, Denmark
Department of Pediatrics, Holbæk Hospital
Holbæk, Denmark
Department of Pediatrics, Hvidovre Hospital
Hvidovre, Denmark
Department of Pediatrics, Kolding Hospital
Kolding, Denmark
Department of Pediatrics, Nykøbing Falster Hospital
Nykøbing Falster, Denmark
Hans Christian Andersen Children's Hospital, Odense University Hospital
Odense, Denmark
Department of Pediatrics, Randers Hospital
Randers, Denmark
Department of Pediatrics, Roskilde University Hospital
Roskilde, Denmark
Department of Pediatrics, Slagelse Hospital
Slagelse, Denmark
Department of Pediatrics, Viborg Hospital
Viborg, Denmark