Overview
Sponsor-declared trial summary
Infectious endocarditis
To study safety and efficacy of a shorter course of antibiotic treatment for infectious endocarditis. Specifically, the study evaluates acellerated antibiotic treatment for left-sided endocarditis caused by any of the bacterial species Staphylococcus aureus, Enterococcus faecalis or streptococci.
Key facts
- Sponsor
- Region Skane
- 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
- 2 Jan 2022 → ongoing
- Decision date (initial)
- 2024-10-17
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-507652-76-00
- EudraCT number
- 2022-001894-29
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy, Safety
To study safety and efficacy of a shorter course of antibiotic treatment for infectious endocarditis. Specifically, the study evaluates acellerated antibiotic treatment for left-sided endocarditis caused by any of the bacterial species Staphylococcus aureus, Enterococcus faecalis or streptococci.
Secondary objectives 1
- The secondary objective is to investigate the economic consequeces of accelerated treatment.
Conditions and MedDRA coding
Infectious endocarditis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Age >18 years. 2. In-patient at a hospital ward. 3. Left-sided endocarditis according to modified Duke's criteria. 4. Verified infection with Stapylococcus aureus, streptococci or Enterococcus faecalis. 5. Obtained informed consent.
Exclusion criteria 1
- 1. Known or suspected immunosuppression such as HIV-infection, ongoing chemotherapy or treatment with corticosteroids in a dose exceeding 20 mg prednisone per day. 2. Unable to give informed consent. 3. Relapse of endocarditis defined as endocarditis caused by the same bacteria within 6 months after a preceeding infection. 4. Endocarditis caused by Staphylococcus aureus in a patient with prosthetic heart valve or cardiovascular implanted device.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary outcome is combined and consists of the following events within 6 months after randomization: a. Death. b. Septic embolization. c. Bacteraemia with the same microorganism. d. Heart surgery not planned at the time of randomization.
Secondary endpoints 1
- a. Expenses related to hospital care and other treatment of the condition. b. Length of hospital stay. c. Length of antibiotic tratment. d. Complications related to intravenous access.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 8
Ceftriaxon Fresenius Kabi 2 g pulver till infusionsvätska, lösning
PRD1962829 · Product
- Active substance
- Ceftriaxone Sodium
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 4 g gram(s)
- Max total dose
- 168 g gram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01DD04 — -
- Marketing authorisation
- 47360
- MA holder
- FRESENIUS KABI AB
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Doktacillin 1g respektive 2 g pulver till injektions/infusionsvätska, lösning
PRD839986 · Product
- Active substance
- Ampicillin
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- 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
- J01CA01 — AMPICILLIN
- Marketing authorisation
- 7195
- MA holder
- VIATRIS AB
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Vancomycin Viatris 1 000 mg pulver till infusionsvätska, lösning
PRD10427270 · Product
- Active substance
- Vancomycin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- 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
- 63256
- MA holder
- VIATRIS LIMITED
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cloxacillin Stragen 2 g pulver till injektions-/infusionsvätska, lösning
PRD9285368 · Product
- Active substance
- Cloxacillin Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- 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
- 59080
- MA holder
- STRAGEN NORDIC A/S
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cefotaxim Stragen 1 g pulver till injektions- och infusionsvätska, lösning
PRD451554 · Product
- Active substance
- Cefotaxime
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 9 g gram(s)
- Max total dose
- 378 g gram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01DD01 — -
- Marketing authorisation
- 21298
- MA holder
- STRAGEN NORDIC A/S
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Bensylpenicillin Meda 3 g pulver till injektions/infusionsvätska, lösning
PRD3365891 · Product
- Active substance
- Benzylpenicillin Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- 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
- J01CE01 — BENZYLPENICILLIN
- Marketing authorisation
- 3521
- MA holder
- MEDA AB
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cubicin 350 mg powder for solution for injection or infusion
PRD3995331 · Product
- Active substance
- Daptomycin
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 700 mg milligram(s)
- Max total dose
- 42.70 g gram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01XX09 — -
- Marketing authorisation
- EU/1/05/328/001
- MA holder
- MERCK SHARP & DOHME BV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Meropenem Fresenius Kabi 1 g pulver till injektionsvätska eller infusionsvätska, lösning
PRD2054443 · Product
- Active substance
- Meropenem Trihydrate
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 6 g gram(s)
- Max total dose
- 252 g gram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01DH02 — MEROPENEM
- Marketing authorisation
- 42757
- MA holder
- FRESENIUS KABI AB
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Skane
- Sponsor organisation
- Region Skane
- Address
- Dockplatsen 26, Malmo S:t Petri Malmo S:t Petri
- City
- Malmo
- Postcode
- 211 74
- Country
- Sweden
Scientific contact point
- Organisation
- Region Skane
- Contact name
- Per Åkesson
Public contact point
- Organisation
- Region Skane
- Contact name
- Per Åkesson
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 50 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Sweden | 2022-01-02 | 2024-01-16 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Studieprotokoll POET II | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | Subject information and consent form | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Bensylpenicillin Meda produktresume | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Cefotaxim Stragen produktresume | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Ceftriaxon Fresenius Kabi produktresume | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Cloxacillin Stragen produktresume | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Daptomycin MSD produktresume | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Doktacillin Meda produktresume | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Meropenem Fresenius Kabi produktresume | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Vancomycin Orion produktresume | 1 |
| Synopsis of the protocol (for publication) | Synopsis POET II | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-06 | Sweden | Acceptable 2024-10-17
|
2024-10-17 |