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RECRUITING
NCT07791914
PHASE4

Oral Switch in Pediatric Bloodstream Infections

Sponsor: Ulrikka Nygaard

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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