NCT07575009 Continuous Antibiotic Infusion In Children
| NCT ID | NCT07575009 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Tampere University Hospital |
| Condition | Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-04-21 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 150 participants in total. It began in 2026-04-21 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07575009 clinical trial?
This trial is open to participants of all sexes, up to 16 Years, studying Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07575009 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 150 participants.
Is NCT07575009 currently recruiting?
Yes, NCT07575009 is actively recruiting participants. Contact the research team at maria.pohjanpaa@pirha.fi for enrollment information.
Where is the NCT07575009 trial being conducted?
This trial is being conducted at Tampere, Finland.
Who is sponsoring the NCT07575009 clinical trial?
NCT07575009 is sponsored by Tampere University Hospital. The trial plans to enroll 150 participants.