Oral switch for kids with bloodstream infections after starting IV therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This nationwide randomized trial in Denmark compares an early switch from intravenous to oral antibiotics to standard IV therapy in children and adolescents with uncomplicated bloodstream infections. It is a parallel-group, open-label, non-inferiority study with 1:1 randomization, stratified by pathogen group. Participants are 4 weeks to 17 years old, previously healthy, and clinically stable, recruited from 18 pediatric departments. The primary outcome is treatment failure within the study period. The study aims to provide evidence on the safety and effectiveness of oral step-down therapy in pediatric bacteremia.

Why it matters

Who can join: the full rules

INCLUSION CRITERIA

1. Age 4 weeks to 17 years
2. 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
3. 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
4. Tolerating oral fluids and diet, as judged by the investigator
5. Within the randomization window (see below)
6. 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)

EXCLUSION CRITERIA

1. 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)
2. 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.)
3. Premature infants with a corrected age of less than 28 days
4. No available suitable oral antibiotic (eg, due to antimicrobial resistance or contraindications)
5. 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.

Where it's running

• Department of Pediatrics, Aabenraa Hospital
  Aabenraa, Denmark Recruiting
• Department of Pediatrics, Aalborg University Hospital
  Aalborg, Denmark Recruiting
• Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Copenhagen University Hospital, Rigshospitalet
  Copenhagen, Denmark Recruiting
• Department of Pediatrics, Esbjerg Hospital
  Esbjerg, Denmark Recruiting
• Department of Paediatrics and adolescent medicine, NIDO Danmark, Gødstrup Hospital
  Gødstrup, Denmark Recruiting

Study contacts

• Principal investigator: Ulrikka Nygaard, MD, PhD, DMSc — Copenhagen University Hospital, Rigshospitalet
• Study coordinator: Ulrikka Nygaard, MD, PhD, DMSc
• Email: Ulrikka.Nygaard@regionh.dk
• Phone: +45 40 79 46 56

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.