RecruitingPhase 3NCT07575009

Continuous Antibiotic Infusion In Children


Sponsor

Tampere University Hospital

Enrollment

150 participants

Start Date

Apr 21, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Continuous intravenous antibiotic infusion using elastomeric pumps is well established in adult care and has been shown to be effective, safe, and cost-efficient, particularly for beta-lactams and vancomycin. In pediatric outpatient parenteral antimicrobial therapy (p-OPAT), home intravenous treatment is feasible and safe, improves quality of life, and reduces hospital stays and healthcare-associated infections. Elastomeric pumps offer practical advantages, including portability, ease of use, fixed infusion rates, and reduced drug handling, although they are limited by fixed flow rates and drug stability. This prospective study at Tampere University Hospital (Tays) will evaluate the safety and cost-effectiveness of 24-hour continuous antibiotic infusions in children between January 2026 and January 2029. Eligible pediatric patients requiring intravenous antimicrobial treatment and suitable for home care will be included. Indications include serious bacterial infections such as bacteremia, osteomyelitis, septic arthritis, neutropenic fever, cystic fibrosis-related infections, and foreign body infections. The study antibiotics are benzylpenicillin, cloxacillin, piperacillin/tazobactam, and vancomycin, administered via CE-approved infusion devices for home use. Children will receive continuous infusion either initially in hospital or directly from the emergency department if appropriate, with treatment duration and dosing comparable to standard intermittent regimens. Outcomes include safety, feasibility, cost-effectiveness, and patient-reported quality of life measured using PedsQL™. The study aims to determine whether continuous infusion can optimize pediatric antimicrobial care and healthcare resource utilization. Results will be published in peer-reviewed international journals.


Eligibility

Max Age: 16 Years

Inclusion Criteria8

  • iv-antibiotic treatment is necessary
  • clinically stable
  • no need to stay in hospital
  • pump or cassette can be changed at the hospital or at home
  • care givers are able to contact hospital if needed
  • clinical diagnose is not uncertain
  • no allergy for the used antibiotic
  • the continuous antibiotic infusion hasn't been started yet or it has been initiated no more than 24 hours prior to study enrolment

Exclusion Criteria3

  • the pump cannot be carried with the child
  • the child must stay at the hospital for monitoring or other reason
  • unclear diagnose

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Interventions

DRUGBenzylpenicillin

Different antibiotics will be used according to the condition being treated


Locations(1)

Pediatric Early Phase Trials Unit (PeeTU), Tampere University Hospital

Tampere, Finland

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NCT07575009


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