Continuous Antibiotic Infusion In Children

NCT07575009 | Recruiting Phase 3

• 2 other identifiers: R26029M2025-522809-38-00
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infection

Keywords

Continuous antibiotic infusion; Children; sepsis; osteomyelitis; Elastomeric pump

Outcome Measures

Primary Outcomes (9)

• Cost of treatment

  Total treatment cost

  From hospitalization to the end of the continuous antibiotic infusion

• Duration of fever

  Number of days from antibiotic initiation to resolution of fever

  From the beginning of the disease to the end of the continuous antibiotic infusion

• 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

  From hospitalization to the end of the continuous antibiotic infusion

• Concomitant medications

  Time from antibiotic initiation to discontinuation of pain/fever medications or other supportive drugs

  From hospitalization to the end of the continuous antibiotic infusion

• Parental absence from work (in days)

  From hospitalization to the end of the continuous antibiotic infusion

• Distance from home to hospital (in kilometers)

  Geographic coverage of care

  In the beginning of the study

• Duration of antibiotic treatment (in days)

  Total duration including inpatient treatment and duration of continuous outpatient antibiotic therapy

  From hospitalization to the end of the continuous antibiotic infusion, up to one month

• Safety, measured with adverse events

  Assessed from study initiation up to three months thereafter

• Emergency or clinic visits

  Assessed from discontinuation of continuous antibiotic infusion up to one month thereafter

Secondary Outcomes (2)

• : The incidence of IV route problems

  From the beginning of continuous antibiotic infusion to the end of the continuous antibiotic infusion, up to one month

• Quality of life of children assessed by PedsQL

  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)

Study Arms (1)

Continuous antibiotic infusion

EXPERIMENTAL

Drug: Benzylpenicillin

Interventions

Benzylpenicillin DRUG

Different antibiotics will be used according to the condition being treated

Also known as: cloxacillin, piperacillin-tazobactam, vancomysin

Continuous antibiotic infusion

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

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

Tampere, 33520, Finland

RECRUITING

MeSH Terms

Conditions

Infections; Sepsis; Osteomyelitis

Interventions

Penicillin G; Cloxacillin; Piperacillin, Tazobactam Drug Combination

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases, Infectious; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Oxacillin; Tazobactam; Penicillanic Acid; Piperacillin; Ampicillin; Sulfones; Drug Combinations; Pharmaceutical Preparations

Central Study Contacts

Maria S Pohjanpää, Pediatrician

CONTACT

+358444728181; maria.pohjanpaa@pirha.fi

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 8, 2026
• Study Start: April 21, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2031
• Last Updated: May 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

FI (1)