Oral Switch in Pediatric Bloodstream Infections

NCT07791914 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: H-25090709
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 18

Brief 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

Keywords

Bloodstream Infection; Bacteremia; Pediatric; Children; Oral switch; CHILD; IV-to-oral switch; Antibiotics

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment Failure

  Treatment failure, defined as clinically and/or microbiologically confirmed disease progression or relapse, adjudicated by an independent, blinded adjudication committee.

  Within 8 weeks of randomization

Secondary Outcomes (1)

• Intravenous Antibiotic Treatment Duration

  Within 8 weeks of randomization

Other Outcomes (4)

• Length of Hospital Stay

  Within 8 weeks of randomization

• Total Antibiotic Treatment Duration

  Within 8 weeks of randomization

• Number of Participants with Reinitiation of Antibiotic Treatment

  Within 8 weeks of randomization

Study Arms (2)

Early Oral Switch

EXPERIMENTAL

Early Oral Switch

Drug: Oral antibiotic therapy

Standard Intravenous Therapy

ACTIVE COMPARATOR

Standard Intravenous Therapy

Drug: Standard IV antibiotic therapy

Interventions

Oral antibiotic therapy DRUG

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.

Early Oral Switch

Standard IV antibiotic therapy DRUG

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.

Standard Intravenous Therapy

Eligibility Criteria

• Age: 4 Weeks - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 4 weeks to 17 years
• Positive blood culture with a i) pathogenic bacterium (eg, Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacterales, Fusobacterium spp. and other pathogenic bacteria) or ii) preliminary blood culture result (eg, Gram-negative rods or Gram-positive cocci in clusters/chains) judged by the investigator to be clinically relevant (ie, not a contaminant) and for which IV antibiotic therapy would be indicated according to standard guidelines
• Clinical stability, defined as: (a) respiratory and haemodynamic stability, without need for oxygen, IV fluid therapy or inotropic support; and (b) well-appearing with signs of clinical improvement (eg, improved physical activity), as judged by the investigator
• Tolerating oral fluids and diet, as judged by the investigator
• Within the randomization window (see below)
• Informed consent obtained from a parent or guardian, and from the patient if aged 15 years or older
• Randomization window:
• Randomization will take place (1) as soon as possible after eligibility is confirmed, and (2) before completion of a maximum of 4 days (96 hours) of effective IV antibiotic therapy, including the duration of the last IV dose (eg, 8 hours for penicillin and 24 hours for ceftriaxone)

You may not qualify if:

• Complicated infections: a. Suspicion of endocarditis (echocardiography not performed routinely), b. Suspicion of CNS infection or post-septal cellulitis, c. Foreign material (eg, bone infection involving prosthetic material). d. Complicated postoperative course (eg, perforated appendicitis)
• Blood culture positive with a. Neisseria meningitidis, b. Streptococcus pneumoniae if afebrile within 24 hours of blood culture collection, c. bacteria considered possible contaminants (eg, coagulase-negative staphylococci, Corynebacterium spp., Micrococcus spp.)
• Premature infants with a corrected age of less than 28 days
• No available suitable oral antibiotic (eg, due to antimicrobial resistance or contraindications)
• Known chronic disease associated with an increased risk of severe infection: i) Immunosuppression, e.g., chemotherapy or biological therapy predisposing to severe infections, ii) Permanent central venous catheter due to an underlying condition, iii) Severe urinary tract abnormalities predisposing to bacteremia, including children receiving prophylactic antibiotic treatment.

Sponsors & Collaborators

• Ulrikka Nygaard: lead

Study Sites (18)

Department of Pediatrics, Aabenraa Hospital

Aabenraa, Denmark

Location

Department of Pediatrics, Aalborg University Hospital

Aalborg, Denmark

Location

Aarhus University Hospital

Aarhus, Denmark

Location

Copenhagen University Hospital, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Department of Pediatrics, Esbjerg Hospital

Esbjerg, Denmark

Location

Department of Paediatrics and adolescent medicine, NIDO Danmark, Gødstrup Hospital

Gødstrup, Denmark

Location

Department of Pediatrics, Herlev Hospital

Herlev, Denmark

Location

Department of Pediatrics, Hillerød Hospital

Hillerød, Denmark

Location

Department of Pediatrics, Hjørring Hospital

Hjørring, Denmark

Location

Department of Pediatrics, Holbæk Hospital

Holbæk, Denmark

Location

Department of Pediatrics, Hvidovre Hospital

Hvidovre, Denmark

Location

Department of Pediatrics, Kolding Hospital

Kolding, Denmark

Location

Department of Pediatrics, Nykøbing Falster Hospital

Nykøbing Falster, Denmark

Location

Hans Christian Andersen Children's Hospital, Odense University Hospital

Odense, Denmark

Location

Department of Pediatrics, Randers Hospital

Randers, Denmark

Location

Department of Pediatrics, Roskilde University Hospital

Roskilde, Denmark

Location

Department of Pediatrics, Slagelse Hospital

Slagelse, Denmark

Location

Department of Pediatrics, Viborg Hospital

Viborg, Denmark

Location

MeSH Terms

Conditions

Sepsis; Bacteremia

Interventions

Anti-Infective Agents

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Ulrikka Nygaard, MD, PhD, DMSc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulrikka Nygaard, MD, PhD, DMSc

CONTACT

+45 40 79 46 56; Ulrikka.Nygaard@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, senior consultant, MD, PhD

Study Record Dates

• First Submitted: August 23, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (18)