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RECRUITING
NCT07575009
PHASE3

Continuous Antibiotic Infusion In Children

Sponsor: Tampere University Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

Any - 16 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-04-21

Completion Date

2031-12-31

Last Updated

2026-05-08

Healthy Volunteers

No

Conditions

Interventions

DRUG

Benzylpenicillin

Different antibiotics will be used according to the condition being treated

Locations (1)

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

Tampere, Finland