Actively Recruiting
Continuous Antibiotic Infusion In Children with Serious Bacterial Infections Using Elastomeric Pumps for Home Treatment
Led by Tampere University Hospital · Updated on 2026-05-08
150
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research evaluates the use of continuous intravenous antibiotic infusion via elastomeric pumps in children with serious bacterial infections. These infections include bacteremia, osteomyelitis, septic arthritis, neutropenic fever, cystic fibrosis-related infections, and foreign body infections. The study aims to assess the safety, cost-effectiveness, and quality of life improvements of 24-hour continuous antibiotic infusions compared to standard treatments. It is conducted at Tampere University Hospital from January 2026 to January 2029. Children eligible for this study will receive antibiotics such as benzylpenicillin, cloxacillin, piperacillin/tazobactam, or vancomycin administered continuously over 24 hours using CE-marked infusion devices suitable for home use, including elastomeric pumps and CADD-Solis VIP devices. Treatment may begin in the hospital ward or emergency department, and if stable, continue at home. Dosage and treatment duration mirror standard intermittent regimens administered several times per day. Participants will be monitored through hospital visits and home care, with safety assessed via adverse events and emergency or clinic visits up to three months after treatment. Researchers will measure treatment costs, fever duration, inflammation markers, medication use, parental work absence, and distance from home to hospital. Quality of life will be evaluated using the PedsQL14 questionnaire at enrollment, treatment end, and follow-up. The study also tracks intravenous route issues during treatment, lasting up to one month.
CONDITIONS
Brief Title
Continuous Antibiotic Infusion In Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Intravenous antibiotic treatment is necessary
- The child is clinically stable
- The child does not need to stay in hospital
- The infusion pump or cassette can be changed at the hospital or at home
- Caregivers are able to contact the hospital if needed
- Clinical diagnosis is certain
- No allergy to the antibiotic used
- Continuous antibiotic infusion has not started yet or started within 24 hours prior to enrollment
- Child is 16 years old or younger
You will not qualify if you...
- The infusion pump cannot be carried with the child
- The child must stay at the hospital for monitoring or other reasons
- Diagnosis is unclear
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of antibiotic treatment (in days) as prescribed, up to one month
Participants receive continuous antibiotic infusion via an elastomeric pump or suitable infusion device, administered as a 24-hour continuous infusion either initially in the hospital ward or emergency room and then continued at home when suitable.
Initial hospital visits followed by home care with regular monitoring visits
Duration - Up to three months after treatment ends
Participants are monitored for safety and quality of life after discontinuation of continuous antibiotic infusion, including assessment of adverse events and emergency or clinic visits.
1 follow-up visit approximately 30 days after treatment ends
Trial Site Locations
Total: 1 location
1
Pediatric Early Phase Trials Unit (PeeTU), Tampere University Hospital
Tampere, Finland, 33520
Actively Recruiting
Research Team
M
Maria S Pohjanpää, Pediatrician
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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