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Oral Switch in Pediatric Bloodstream Infections

NCT07791914 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-08-28

No results posted yet for this study

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.

Conditions

  • Bloodstream Infection
  • Bacteremia Sepsis

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.

Sponsors & Collaborators

  • Ulrikka Nygaard

    lead OTHER

Principal Investigators

  • Ulrikka Nygaard, MD, PhD, DMSc · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Weeks
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2029-11-01
Completion
2029-11-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07791914 on ClinicalTrials.gov