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InfectionPhase 3NCT07575009

Continuous Antibiotic Infusion In Children

A Phase 3 study testing Benzylpenicillin in people with Infection, run by Tampere University Hospital at 1 site in Finland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 16 years
Conditions the study is for
Infection
What is being tested?
Benzylpenicillin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteFinland
Study dates
21 Apr 2026to 31 Dec 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Maria S Pohjanpää, Pediatrician contact

+358444728181

maria.pohjanpaa@pirha.fi

Finland1 site, 1 recruiting
  • Pediatric Early Phase Trials Unit (PeeTU), Tampere University Hospital

    Tampere, 33520

    Heidi Alanen, Study Coordinator, +358505112371, heidi.alanen@pirha.fi

    Recruiting

Other trials in Finland

About this study

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.

Read the detailed description

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.

Conditions
Infection
Being tested
Benzylpenicillin
Keywords
Continuous antibiotic infusion, Children, sepsis, osteomyelitis, Elastomeric pump
Medical subject headings
Infections, Sepsis, Osteomyelitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BenzylpenicillinDrug

    Also called cloxacillin, piperacillin-tazobactam, vancomysin

    Different antibiotics will be used according to the condition being treated

Study groups in NCT07575009
Study groupRoleWhat they receive
Continuous antibiotic infusionExperimentalNot described
Receives: Drug: Benzylpenicillin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cost of treatment

    Total treatment cost

    Measured: From hospitalization to the end of the continuous antibiotic infusion

  2. Duration of fever

    Number of days from antibiotic initiation to resolution of fever

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

  3. 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

    Measured: From hospitalization to the end of the continuous antibiotic infusion

  4. Concomitant medications

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

    Measured: From hospitalization to the end of the continuous antibiotic infusion

  5. Parental absence from work (in days)

    Measured: From hospitalization to the end of the continuous antibiotic infusion

  6. Distance from home to hospital (in kilometers)

    Geographic coverage of care

    Measured: In the beginning of the study

  7. Duration of antibiotic treatment (in days)

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

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

  8. Safety, measured with adverse events

    Measured: Assessed from study initiation up to three months thereafter

  9. Emergency or clinic visits

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

Secondary outcomes (2)
  1. : The incidence of IV route problems

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

  2. 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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2026
  2. Study start21 Apr 2026
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07575009
Sponsor's protocol ID
R26029M
Other IDs
2025-522809-38-00, 2025
Status last verified
Apr 2026
First submitted
22 Apr 2026
Last updated
8 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Pseudonymized data will be provided upon reasonable request

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Benzylpenicillin in people with Infection, run by Tampere University Hospital at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maria S Pohjanpää, Pediatrician (+358444728181, maria.pohjanpaa@pirha.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cost of treatment (time frame: From hospitalization to the end of the continuous antibiotic infusion). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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