Clinical trial • Not applicable • Infectious Disease

BENZYLPENICILLIN SODIUM for Staphylococcus aureus bacteraemia | Staphylococcus aureus bacteremia

Not applicable trial of BENZYLPENICILLIN SODIUM for Staphylococcus aureus bacteraemia | Staphylococcus aureus bacteremia.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Staphylococcus aureus bacteraemia | Staphylococcus aureus bacteremia
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
09-11-2023
First CTIS Authorization Date
09-02-2024

Trial design

Randomised, cloxacillin navamedic 2 g (intravenous; comparator arm)-controlled Not applicable trial in Sweden.

Randomised
Yes
Comparator
Cloxacillin Navamedic 2 g (intravenous; comparator arm)
Target Sample Size
420
Trial Duration For Participant
90

Eligibility

Recruits 420 Vulnerable population selected; participants must be able to give informed consent (inclusion criterion: 'Abiliaty to give informed consent'). No further details on assent or additional consent procedures provided..

Vulnerable Population
Vulnerable population selected; participants must be able to give informed consent (inclusion criterion: 'Abiliaty to give informed consent'). No further details on assent or additional consent procedures provided.

Inclusion criteria

  • {"criterion_text":"- > 18 years with penicillin susceptible S. aureus bacteraemia\n- Abiliaty to give informed consent"}

Exclusion criteria

  • {"criterion_text":"- Allergy to penicillin\n- More than one significant bacterial species in blood cultures.\n- ≥ 96h of antibiotic treatment before inclusion\n- Verified or strong suspicion of prosthetic joint infection\n- Terminal ill patients with a suscpected survival less than 7 days"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Alive at day 90 without complications. Complications defined as; relapse within 90 days from finishing antibiotic treatment, Change or addition of antibiotic treatment due to adverse events or clinical failure.","definition_or_measurement_approach":"Complications defined as relapse within 90 days from finishing antibiotic treatment; change or addition of antibiotic treatment due to adverse events or clinical failure. Primary outcome assessed as alive at day 90 without these complications."}

Recruitment

Planned Sample Size
420
Recruitment Window Months
48
Consent Approach
Participants must be capable of giving informed consent (inclusion criterion: 'Abiliaty to give informed consent'). No information available on assent procedures, age-specific documents, or languages in the provided record.

Geography

Total Number Of Sites
14
Total Number Of Participants
420

Sweden

Earliest CTIS Part Ii Submission Date
22-01-2024
Latest Decision Or Authorization Date
15-11-2024
Processing Time Days
298
Number Of Sites
14
Number Of Participants
420

Sites

Site Name
Region Skane Kristianstad Central Hospital
Department Name
Infektionskliniken
Contact Person Name
Josefin Frisk
Contact Person Email
josefin.frisk@skane.se
Site Name
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Department Name
Infektionskliniken
Contact Person Name
Daniel Bremell
Contact Person Email
daniel.bremell@infect.gu.se
Site Name
Region Skane Helsingborg Hospital
Department Name
Infektionskliniken
Contact Person Name
Oskar Ljungquist
Contact Person Email
oskar.ljungquist@skane.se
Site Name
Region Uppsala
Department Name
Infektionskliniken
Contact Person Name
Thomas Tängdén
Contact Person Email
thomas.tangden@medsci.uu
Site Name
Karolinska University Hospital
Department Name
Infektionskliniken H7 infektion och Hud
Contact Person Name
Hilmir Asgeirsson
Site Name
Vasteras Central Hospital
Department Name
Infektionskliniken
Contact Person Name
Gabriel Heyman
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Infektionskliniken, Hälsogatan 3
Contact Person Name
Malin Hagstrand Aldman
Site Name
Region Blekinge
Department Name
Infektionskliniken
Contact Person Name
Mårten Larsson
Site Name
Region Oerebro Laen
Department Name
Infektionskliniken
Contact Person Name
Sara Cajander
Site Name
NU Hospital Group-Vaestra Goetalandsregionen
Department Name
Infektionskliniken
Contact Person Name
Johanna Karlsson
Contact Person Email
johanna.karlsson@vregion.se
Site Name
Soedra Aelvsborg Hospital Vaestra Goetalandsregionen
Department Name
Infektionskliniken
Contact Person Name
Agnes Dickèr
Contact Person Email
agnes.dicker@vregion.se
Site Name
Region Vaesternorrland
Department Name
Infektionskliniken
Contact Person Name
Björn Diedrichs
Contact Person Email
bjorn.diedrichs@rvn.se
Site Name
Region Skane Skanes Universitetssjukhus (Malmo St Johannes)
Department Name
Infektionskliniken
Contact Person Name
Viktor Månsson
Contact Person Email
viktor.mansson@skane.se
Site Name
Region Stockholm
Department Name
Infektionskliniken
Contact Person Name
Karolin Falconer
Contact Person Email
karolin.falconer@sll.se

Sponsor

Primary sponsor

Full Name
Region Skane
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
Bensylpenicillin Meda 1 g respektive 3 g pulver till injektions/infusionsvätska, lösning
Active Substance
BENZYLPENICILLIN SODIUM
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
12 g
Investigational Product Name
Cloxacillin Navamedic 2 g pulver till injektions-/infusionsvätska, lösning
Active Substance
CLOXACILLIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
12 g

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