Continuous Antibiotic Infusion In Children
ConditionInfection
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeUp to 16
SponsorTampere University Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
the pump cannot be carried with the child
the child must stay at the hospital for monitoring or other reason
unclear diagnose
Trial design
Design model
Single group
Treatments tested in this trial
Benzylpenicillin
DrugDifferent antibiotics will be used according to the condition being treated
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Continuous antibiotic infusionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cost of treatment
Total treatment cost
Time frame
From hospitalization to the end of the continuous antibiotic infusion2
Duration of fever
Number of days from antibiotic initiation to resolution of fever
Time frame
From the beginning of the disease to the end of the continuous antibiotic infusion3
Change in C-reactive protein (CRP) mg/ml
Number of days from antibiotic initiation to normalization of values. Blood test are taken from all patiens D1 and D3
Time frame
From hospitalization to the end of the continuous antibiotic infusion4
Concomitant medications
Time from antibiotic initiation to discontinuation of pain/fever medications or other supportive drugs
Time frame
From hospitalization to the end of the continuous antibiotic infusionSecondary outcomes
1
: The incidence of IV route problems
Time frame
From the beginning of continuous antibiotic infusion to the end of the continuous antibiotic infusion, up to one month2
Quality of life of children assessed by PedsQL
The questionnaire include scores of Physical Functioning, Emotional Functioning, Social Functioning, School Functioning, Total score, Psychosocial health summary score and Physical health summary score. Scores are transformed on a scale from 0 to 100. Higher scores means better Healt-Related Quality of Life.
Time frame
At the enrollment, at the discontinuation of continuous antibiotic infusion and at the follow up visit (30 days +/- 3 days from the discontinuation of antibiotic infusion)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov