A Phase 3 interventional study of Benzylpenicillin in Infection, sponsored by Tampere University Hospital. Recruiting at 1 site in Finland. Open to participants aged Up to 16 Years. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Tampere University Hospital · Phase 3, Interventional, and Treatment
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.
Continuous antibiotic infusion has long been used in adults, administered via elastomeric devices.
The most used antibiotics are beta-lactams (benzylpenicillin, cloxacillin, piperacillin-tazobactam) and glycopeptides (vancomycin), and these are also in use in adults' home hospital unit at Tampere University Hospital (Tays). Several studies have found that beta-lactam antibiotics are as effective or even more effective when administered as a continuous infusion compared to intermittent infusions. Continuous infusion via an elastomeric pump has been found to be safe in adult outpatient care. Intravenous antibiotic therapy at home for children (paediatric outpatient parenteral antimicrobial therapy, p-OPAT) has been found to be both feasible and safe. It has been shown to increase parental and patient satisfaction, mental well-being, and return to school, as well as reduce healthcare-associated infections and bring cost savings. In previous publications from pediatric population, continuous antibiotic infusion via an elastomeric device have shown to be safe. Elastomeric pumps have found to have many benefits.
They are disposable, portable, lightweight, closed, and pre-filled, reducing drug handling. Pumps have a constant rate, preventing programming errors, and are relatively inexpensive (depending on the drug cost). The disadvantages are that the pumps are in the fixed size and flow rate of the device, the need for pharmacy involvement for each fill, and the choice of antimicrobial therapy being dependent on drug stability. Prolonged and continuous antibiotic infusions have shown a greater probability of reaching targeted antimicrobial levels compared to intermittent infusion regimens, and generally have good clinical outcomes, tolerability, and safety profile. They also have cost benefits and may reduce the length of hospitalization in adults. The aim of this study is to investigate continuous (24h) antibiotic infusions in children at Tays and aims to study the cost-effectiveness and safety of continuous antibiotic infusions via elastomeric pump or another suitable infusion device. The study will prospectively include children treated at Tampere University Hospital with antimicrobial treatment requiring intravenous administration and suitable for infusion via elastomeric pump. Such patients could include for example patients with neutropenic fever, osteomyelitis, septic arthritis, infections with positive blood culture/bacteremia, patients with cystic fibrosis or foreign body infections. Other children who meet the criteria for suitable intravenous antibiotic treatment will also be included. The antibiotics used in the study are benzylpenicillin, cloxacillin, piperacillin/tazobactam and vancomycin. Patients are recruited during the next three years 01/2026-01/2029. The children included in the study are treated with continuous antibiotic infusion and are suitable for home care the same way as the patients with intermittent antibiotic infusion. Antibiotic treatment will be administered as a 24-hour continuous infusion. The first two patients in each antibiotic group will receive continuous infusion treatment in the ward at the beginning of the infusion, and if the treatment proceeds without problems, it will continue at home. Later, patients may receive antimicrobial treatment via elastomeric pump at first-line treatment in the emergency room or patients with antimicrobial 5 treatment administered as boluses can be transmitted for elastomeric pump. The duration of antibiotic treatment and used antimicrobe will be the same as for intermittent infusions administered several times per day in hospital. Antibiotic dosage depends on several factors, such as the child's weight, age, the type and site of infection, severity of infection, patient's medical history, local resistance patterns and the causative bacterium. Children admitted to the ward with intermittent antibiotic treatment requiring prolonged intravenous treatment may also be recruited for the study, if continuous antimicrobial treatment is estimated as beneficial. Prolonged intravenous treatment is defined as well-being child with only reason to continue treatment in hospital ward is the need of intravenous antimicrobial treatment (no other surveillance, ventilation support etc) The study will be performed in the pediatric ward, pediatric emergency department and pediatric home hospital of The Wellbeing Services County of Pirkanmaa (Pirha). In the study, continuous antibiotic infusion will be via an elastomeric pump (Baxter), CADD-Solis VIP infusion device, or another suitable infusion device. The study uses only CE-marked infusion pumps that, according to the manufacturer's stated intended use, are approved for home use in children In Finland, continuous antibiotic infusions are already used to some extent in children in various hospitals, but to our knowledge, no research has been conducted in the Nordic countries and none including the cost-effectiveness. Continuous antibiotic infusion allows children to stay at home instead of in the hospital in certain situations. The investigators will assess the perceived quality of life of children using a validated quality of life questionnaire PedsQLTM. The aim is to determine whether the use of continuous antibiotic infusions could be cost-effective and thus optimize healthcare resources.
Reports from the sub-studies will be prepared and submitted for publication in an international peer-reviewed medical journal.
2,093 studies on the registry are indexed under Infections; 364 are open to participants now.
This study's planned enrollment of 150 is above the median of 113 across 1,304 interventional studies indexed under Infections.
Browse Infections studies →Tampere University Hospital is the lead sponsor of 212 studies on the registry; 56 are open to participants now.
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Exclusion Criteria:
Drug: Benzylpenicillin
Different antibiotics will be used according to the condition being treated
Also known as: cloxacillin, piperacillin-tazobactam, vancomysin
Cost of treatment
Total treatment cost
Time frame: From hospitalization to the end of the continuous antibiotic infusion
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 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
Time frame: 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
Time frame: From hospitalization to the end of the continuous antibiotic infusion
Parental absence from work (in days)
Time frame: From hospitalization to the end of the continuous antibiotic infusion
Distance from home to hospital (in kilometers)
Geographic coverage of care
Time frame: In the beginning of the study
Duration of antibiotic treatment (in days)
Total duration including inpatient treatment and duration of continuous outpatient antibiotic therapy
Time frame: From hospitalization to the end of the continuous antibiotic infusion, up to one month
Safety, measured with adverse events
Time frame: Assessed from study initiation up to three months thereafter
Emergency or clinic visits
Time frame: Assessed from discontinuation of continuous antibiotic infusion up to one month thereafter
: 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 month
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)
Plan to share: Yes — Pseudonymized data will be provided upon reasonable request
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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Studies of the drug tested here: Penicillin G