Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
2,000
Countries
1
Sites
9
Sepsis
In patients with suspected community acquired sepsis, assess whether combination therapy with narrow spectrum betalactam (penicillin, ampicillin, cloxacillin) and aminoglycoside (gentamicin) is safe and non-inferior to therapy with broad spectrum antibiotics (cefotaxime, piperacillin-tazobactam)
Key facts
- Sponsor
- Akershus University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 1 Jul 2025 → ongoing
- Decision date (initial)
- 2025-07-01
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519797-39-00
- ClinicalTrials.gov
- NCT06712641
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
In patients with suspected community acquired sepsis, assess whether combination therapy with narrow spectrum betalactam (penicillin, ampicillin, cloxacillin) and aminoglycoside (gentamicin) is safe and non-inferior to therapy with broad spectrum antibiotics (cefotaxime, piperacillin-tazobactam)
Conditions and MedDRA coding
Sepsis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10040047 | Sepsis | 100000004862 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Hospitalized
- Adults 18 year or older
- Clinical suspicion of community acquired sepsis with indication for empirical antibiotic therapy
- National Early Warning Score 2 (NEWS2) ≥ 5
- Signed informed consent must be obtained and documented according to ICH GCP, and national/local regulations
Exclusion criteria 11
- Established chronic kidney failure (eGFR < 30 ml/min/1.73m2)
- Presentation with septic shock with multiorgan failure
- Suspicion of condition necessitating specific antimicrobial therapy (e.g. atypical pneumonia, fungal infection, parasitic infection, mycobacterial infection)
- Current or recent use of nephrotoxic drugs (e.g cisplatin within previous 2 months)
- Suspected or confirmed carrier of extended spectrum betalactamase (ESBL) producing bacteria, methicillin-resistant Staphylococcus aureus (MRSA), or other drug-resistant microbes necessitating specific antimicrobial therapy
- Multiple myeloma
- Renal transplantation
- Renal replacement therapy
- Myasthenia gravis
- Known hypersensitivity to any of the study drugs
- Pregnancy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Death up to 30 days after randomization
- Any acute kidney injury up to 30 days after randomization
Secondary endpoints 8
- In-hospital mortality
- Mortality up to 30 days after discharge
- Duration of hospital stay
- Duration of intensive care stay
- Duration of ventilator therapy
- Duration of vasopressor therapy
- Hospital readmissions up to 30 days after discharge
- Duration of antibiotic treatment
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
SCP104123707 · ATC
- Active substance
- Benzylpenicillin Procaine
- Substance synonyms
- PROCAINE BENZYLPENICILLIN, PENICILLIN G PROCAINE, PENICILLIN PROCAINE
- Route of administration
- INTRAVENOUS
- Max daily dose
- 18 g gram(s)
- Max total dose
- 0 g gram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- J01CE01 — BENZYLPENICILLIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP12505097 · ATC
- Active substance
- Betamethasone Valerate
- Substance synonyms
- BETAMETHASONE 17-VALERATE
- Route of administration
- INTRAVENOUS
- Max daily dose
- 700 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- J01GB03 — GENTAMICIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP106362797 · ATC
- Active substance
- Ampicillin Sodium
- Route of administration
- INTRAVENOUS
- Max daily dose
- 12 g gram(s)
- Max total dose
- 0 g gram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- J01CA01 — AMPICILLIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP102640673 · ATC
- Active substance
- Cloxacillin
- Route of administration
- INTRAVENOUS
- Max daily dose
- 12 g gram(s)
- Max total dose
- 0 g gram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- J01CF02 — CLOXACILLIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 2
SCP1153878 · ATC
- Active substance
- Piperacillin Sodium
- Route of administration
- INTRAVENOUS
- Max daily dose
- 16 g gram(s)
- Max total dose
- 0 g gram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- J01CR05 — PIPERACILLIN AND BETA-LACTAMASE INHIBITOR
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1143957 · ATC
- Active substance
- Cefotaxime
- Route of administration
- INTRAVENOUS
- Max daily dose
- 12 g gram(s)
- Max total dose
- 0 g gram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- J01DD01 — CEFOTAXIME
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Akershus University Hospital
- Sponsor organisation
- Akershus University Hospital
- Address
- Sykehusveien 25
- City
- Loerenskog
- Postcode
- 1474
- Country
- Norway
Scientific contact point
- Organisation
- Akershus University Hospital
- Contact name
- Jan Erik Berdal
Public contact point
- Organisation
- Akershus University Hospital
- Contact name
- Jan Erik Berdal
Locations
1 EU/EEA country · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Norway | Ongoing, recruiting | 2,000 | 9 |
| Rest of world | — | 0 | — |
Investigational sites
Universitetssykehuset Nord-Norge HF
Department of Infectious Diseases, Sykehusvegen 38, 9019, Tromsoe
Sykehuset I Vestfold HF
Department of Infectious Diseases, Halfdan Wilhelmsens Alle 17, 3116, Toensberg
Vestre Viken HF
General internal medicine and infectious diseases, Jacob Borchs Gate 10, 3004, Drammen
Nordlandssykehuset HF
Department of Infectious Diseases, Parkveien 95, 8005, Bodo
Akershus University Hospital
Infectious diseases, Sykehusveien 27, 1478, Lorenskog
Helse Bergen HF
Department of Infectious Diseases, Haukelandsveien 22, 5021, Bergen
Lovisenberg Diakonale Sykehus AS
Department of Infectious Diseases, Lovisenberggata 17, 0456, Oslo
St. Olavs Hospital HF
Department of Infectious Diseases, Prinsesse Kristinas Gate 3, 7030, Trondheim
Oslo University Hospital HF
Infectious diseases, P. O. Box 4950, 0424, Oslo
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Norway | 2025-07-01 | 2026-04-23 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 17 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-519797-39-00 | 1.2 |
| Protocol (for publication) | D1_Protocol 2024-519797-39-00 TC | 1.2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements TC | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF delayed | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF delayed next-of-kin | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF next-of-kin | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF normal | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF reservation | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF reservation next-of-kin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC ampicillin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC cefotaxim | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC cloxacillin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC gentamicin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC penicillin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC piperacillin_tazobactam | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NO 2024-519797-39-00 | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-16 | Norway | Acceptable 2025-06-27
|
2025-07-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-21 | Norway | Acceptable 2025-12-19
|
2025-12-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-06 | Norway | Acceptable 2026-03-24
|
2026-03-24 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-05-13 | Norway | Acceptable | 2026-05-22 |