Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
150
Countries
1
Sites
1
Infection disease
To evaluate the efficacy, safety and cost-efficiency of continuous (24 h) antibiotic infusion in children
Key facts
- Sponsor
- Pirkanmaan hyvinvointialue
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Decision date (initial)
- 2026-02-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacoeconomic, Therapy, Safety
To evaluate the efficacy, safety and cost-efficiency of continuous (24 h) antibiotic infusion in children
Secondary objectives 1
- To assess the perceived quality of life of children and their parents using a validated quality of life questionnaire and iv-route problems
Conditions and MedDRA coding
Infection disease
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- 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 3
- The pump cannot be carried with the child
- The child must stay at the hospital for monitoring or other reason
- Unclear diagnose
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Duration of hospital stay / fever / antibiotic treatment
- Readmission to hospital
- Possible relapse (defined separately for each patient case)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
Benzylpenicillin Fresenius Kabi 1,2 g (2 milj. IU) injektio-/infuusiokuiva-aine liuosta varten
PRD11236215 · Product
- Active substance
- Benzylpenicillin Sodium
- Substance synonyms
- PENICILLIN G SODIUM, SODIUM PENICILLIN
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 20000000 IU international unit(s)
- Max total dose
- 840000000 IU international unit(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01CE01 — BENZYLPENICILLIN
- Marketing authorisation
- 41612
- MA holder
- FRESENIUS KABI AB
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cloxacillin Navamedic 2 g injektio-/infuusiokuiva-aine liuosta varten
PRD10369206 · Product
- Active substance
- Cloxacillin
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 12 g gram(s)
- Max total dose
- 504 g gram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01CF02 — CLOXACILLIN
- Marketing authorisation
- 41658
- MA holder
- NAVAMEDIC ASA
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Piperacillin/Tazobactam Kalceks 2 g/0,25 g infuusiokuiva-aine, liuosta varten
PRD10276998 · Product
- Active substance
- Piperacillin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 12 g gram(s)
- Max total dose
- 504 g gram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01CR05 — PIPERACILLIN AND ENZYME INHIBITOR
- Marketing authorisation
- 40130
- MA holder
- KALCEKS
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Vancosan 500 mg, Infuusiokuiva-aine, liuosta varten
PRD11818669 · Product
- Active substance
- Vancomycin Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 3 g gram(s)
- Max total dose
- 126 g gram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01XA01 — VANCOMYCIN
- Marketing authorisation
- 28525
- MA holder
- MIP PHARMA GMBH
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pirkanmaan hyvinvointialue
- Sponsor organisation
- Pirkanmaan hyvinvointialue
- Address
- Elamanaukio 2
- City
- Tampere
- Postcode
- 33520
- Country
- Finland
Scientific contact point
- Organisation
- Pirkanmaan hyvinvointialue
- Contact name
- Maria Pohjanpää
Public contact point
- Organisation
- Pirkanmaan hyvinvointialue
- Contact name
- Maria Pohjanpää
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 150 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 16 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1__Protocol_EU CT 2025-522809-38-00 | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 12-14 yr_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 12-14_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF 15-16 yr redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_12-14y | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_15-16y | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Guardian | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Guardian_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Notfication Guardian_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_under 12 yr_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_under 12v | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Bentsyylipenisilliini | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Kloksasilliini | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Piperasilliini-tatsobaktaami | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Vankomysiini | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-12 | Finland | Acceptable 2026-01-29
|
2026-02-16 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-18 | Finland | Acceptable 2026-01-29
|
2026-02-18 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-02-20 | Finland | Acceptable | 2026-03-16 |