Oral switch for bloodstream infections in immunocompromised children

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 is a nationwide, multicenter randomized non-inferiority study enrolling children and adolescents with uncomplicated bloodstream infections who are immunocompromised or have a central venous catheter. Participants are randomized to receive an early switch to oral antibiotics or continue standard IV therapy, with the aim of not increasing recurrence of infection. The study targets clinically stable patients aged 4 weeks to 17 years and evaluates the non-inferiority of the oral switch in preventing recurrent bloodstream infection. The primary setting includes pediatric departments across multiple Danish hospitals. Results could change guidelines on IV vs oral antibiotics in this specific pediatric population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 4 weeks to 17 years
2. Underlying medical condition associated with immunosuppression and/or presence of a central venous catheter
3. Positive blood culture with a high-pathogenic bacterium. Eligible pathogens include Gram-negative bacteria and Gram-positive bacteria such as Staphylococcus aureus, Streptococcus mitis, Streptococcus pneumoniae, β-haemolytic streptococci, and Enterococcus spp., for which standard treatment is at least 7 days of intravenous antibiotics.
4. Clinical stability, defined as: (a) respiratory and hemodynamically stable, without need for oxygen, IV fluid therapy or inotropic support; and (b) well-appearing with signs of clinical improvement (e.g., improved physical activity), as judged by the investigator
5. Afebrile for 24 hours.
6. Tolerating oral fluids and diet and considered to have adequate gastrointestinal absorption for age, as judged by the investigator
7. Within the randomization window: i) As soon as possible after eligibility is confirmed and ii) within 3-6 days of effective IV antibiotics (72-144 hours) including the duration of the last IV dose.
8. Informed consent obtained from a parent or guardian, and from the patient if of appropriate age.

Polymicrobial episodes are allowed

Exclusion Criteria:

1. Complicated infections

   1. Tunnel infection associated with a CVC, unless the CVC is removed
   2. Suspected CNS infection
   3. Other focal infections requiring prolonged antibiotic therapy beyond the treatment of bacteremia, e.g., deep-seated abscess or other deep-seated infections, bone or joint infections, and endocarditis
2. Blood culture with Pseudomonas aeruginosa, Neisseria meningitidis, or low-pathogenic possible contaminants of uncertain clinical relevance, including coagulase-negative staphylococci, Micrococcus spp., Corynebacterium spp., Cutibacterium acnes, and Bacillus spp.
3. Clinically significant mucositis (e.g. stomatitis CTCAE (Common Terminology Criteria for Adverse Events) grade ≥3, defined as severe pain interfering with oral intake)
4. No suitable oral antibiotic available (e.g., due to antimicrobial resistance or contraindications)
5. Within the follow-up period (≤6 weeks) of a previous randomization for another pathogen covered by the antibiotic indicated for the index episode.
6. Planned to receive prophylactic antibiotic therapy covering the pathogen after completion of treatment for the index infection
7. A decision to discontinue life-prolonging treatment has been made, with a life expectancy of less than 6 weeks, as assessed by the treating physician.

Where it's running

• Department of Pediatrics, Aalborg University Hospital
  Aalborg, Denmark Recruiting
• Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Copenhagen University Hospital
  Copenhagen, Denmark Recruiting
• Hans Christian Andersen Children's Hospital, Odense University Hospital
  Odense, Denmark Recruiting

Study contacts

• Study coordinator: Ulrikka Nygaard, MD, PhD, DrMedSci
• Email: ulrikka.nygaard@regionh.dk
• Phone: +4540794656

Similar studies

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

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• Personalized immunological score to predict severe infections in transplant and immunocompromised patients

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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.