24-hour continuous antibiotic infusion for children using portable elastomeric pumps
Continuous Antibiotic Infusion In Children
This will try 24-hour continuous IV antibiotic infusions with portable elastomeric pumps for children who need intravenous antibiotics to see if the approach is safe and cost-saving for home care.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | N/A to 16 Years |
| Sex | All |
| Sponsor | Tampere University Hospital Academic / other |
| Locations | 1 site (Tampere) |
| Trial ID | NCT07575009 on ClinicalTrials.gov |
What this trial studies
This is a prospective Phase 3 interventional program at Tampere University Hospital enrolling clinically stable pediatric patients who require IV antibiotics and are suitable for home care. Enrolled children will receive 24-hour continuous antibiotic infusion delivered by elastomeric pumps (commonly beta-lactams such as benzylpenicillin), with pumps changed either at the hospital or at home and caregivers trained to contact the hospital as needed. The protocol will monitor safety outcomes, treatment adherence, and health-care resource use to determine cost-effectiveness compared with conventional care. Recruitment and follow-up occur between January 2026 and January 2029 at the Pediatric Early Phase Trials Unit in Tampere.
Who should consider this trial
Good fit: Children who need IV antibiotic treatment, are clinically stable, have a clear diagnosis with no allergy to the planned antibiotic, can carry the pump, and whose caregivers can manage home care and contact the hospital are ideal candidates.
Not a fit: Children who are clinically unstable, require inpatient monitoring, have an unclear diagnosis, cannot carry the pump, or are allergic to the study antibiotic are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the approach could allow more children to complete IV antibiotic courses at home, improving quality of life and reducing hospital stays and costs.
How similar studies have performed: Continuous infusion via elastomeric pumps is well established and shown to be effective and safe in adults, and smaller pediatric reports suggest safety though large pediatric randomized data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * the pump cannot be carried with the child * the child must stay at the hospital for monitoring or other reason * unclear diagnose
Where this trial is running
Tampere
- Pediatric Early Phase Trials Unit (PeeTU), Tampere University Hospital — Tampere, Finland (Recruiting)
Study contacts
- Study coordinator: Maria S Pohjanpää, Pediatrician
- Email: maria.pohjanpaa@pirha.fi
- Phone: +358444728181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.