Actively Recruiting

Phase 3
Age: 0 - 16Years
All Genders
NCT07575009

Continuous Antibiotic Infusion In Children

Led by Tampere University Hospital · Updated on 2026-05-08

150

Participants Needed

1

Research Sites

297 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Continuous Antibiotic Infusion In Children

Who Can Participate

Age: 0 - 16Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Intravenous antibiotic treatment is necessary
  • Child is clinically stable
  • No need for hospital stay
  • Pump or cassette can be changed at hospital or at home
  • Caregivers can contact hospital if needed
  • Diagnosis is clear and not uncertain
  • No allergy to the antibiotic used
  • Continuous antibiotic infusion has not started or started no more than 24 hours before enrollment
Not Eligible

You will not qualify if you...

  • Pump cannot be carried by the child
  • Child must stay in hospital for monitoring or other reasons
  • Diagnosis is unclear

AI-Screening

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Trial Site Locations

Total: 1 location

1

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

Tampere, Finland, 33520

Actively Recruiting

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Research Team

M

Maria S Pohjanpää, Pediatrician

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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