Clinical trial • Infectious Disease

VANCOMYCIN for Infective endocarditis

Clinical trial of VANCOMYCIN for Infective endocarditis. Randomised. 50 participants.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Infective endocarditis
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
06-10-2024
First CTIS Authorization Date
17-10-2024

Trial design

Randomised trial across 1 site in Sweden.

Randomised
Yes
Target Sample Size
50
Trial Duration For Participant
182

Eligibility

Recruits 50 Vulnerable population not selected. Exclusion criterion includes: 'Unable to give informed consent.' Participants must provide informed consent (adults only)..

Vulnerable Population
Vulnerable population not selected. Exclusion criterion includes: 'Unable to give informed consent.' Participants must provide informed consent (adults only).

Inclusion criteria

  • {"criterion_text":"- 1. Age >18 years."}
  • {"criterion_text":"- 2. In-patient at a hospital ward."}
  • {"criterion_text":"- 3. Left-sided endocarditis according to modified Duke's criteria."}
  • {"criterion_text":"- 4. Verified infection with Stapylococcus aureus, streptococci or Enterococcus faecalis."}
  • {"criterion_text":"- 5. Obtained informed consent."}

Exclusion criteria

  • {"criterion_text":"- 1. Known or suspected immunosuppression such as HIV-infection, ongoing chemotherapy or treatment with corticosteroids in a dose exceeding 20 mg prednisone per day."}
  • {"criterion_text":"- 2. Unable to give informed consent."}
  • {"criterion_text":"- 3. Relapse of endocarditis defined as endocarditis caused by the same bacteria within 6 months after a preceeding infection."}
  • {"criterion_text":"- 4. Endocarditis caused by Staphylococcus aureus in a patient with prosthetic heart valve or cardiovascular implanted device."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Composite endpoint assessed within 6 months after randomization: occurrence of any of the listed events (death; septic embolization; bacteraemia with the same microorganism; unplanned heart surgery)."}

Secondary endpoints

  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Economic and resource use outcomes (expenses), hospital length of stay, duration of antibiotic treatment, and complications related to intravenous access as recorded during treatment and follow-up."}

Recruitment

Planned Sample Size
50
Recruitment Window Months
53
Consent Approach
Informed consent must be obtained from participants; inability to give informed consent is an exclusion. No details on assent, age-specific documents or languages provided in the record.

Geography

Total Number Of Sites
1
Total Number Of Participants
50

Sweden

Earliest CTIS Part Ii Submission Date
04-09-2023
Latest Decision Or Authorization Date
17-10-2024
Processing Time Days
409
Number Of Sites
1
Number Of Participants
50

Sites

Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Departnetn of Infectious Diseases
Principal Investigator Name
Per Åkesson
Principal Investigator Email
per.akesson@skane.se
Contact Person Name
Per Åkesson
Contact Person Email
per.akesson@skane.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
Vancomycin Viatris 1 000 mg pulver till infusionsvätska, lösning
Active Substance
VANCOMYCIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
marketingAuthNumber: 63256; authorisationCountryCode: SE
Maximum Dose
3 g per day
Investigational Product Name
Meropenem Fresenius Kabi 1 g pulver till injektionsvätska eller infusionsvätska, lösning
Active Substance
MEROPENEM TRIHYDRATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
marketingAuthNumber: 42757; authorisationCountryCode: SE
Maximum Dose
6 g per day
Investigational Product Name
Ceftriaxon Fresenius Kabi 2 g pulver till infusionsvätska, lösning
Active Substance
CEFTRIAXONE SODIUM
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
marketingAuthNumber: 47360; authorisationCountryCode: SE
Maximum Dose
4 g per day
Investigational Product Name
Bensylpenicillin Meda 3 g pulver till injektions/infusionsvätska, lösning
Active Substance
BENZYLPENICILLIN SODIUM
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
marketingAuthNumber: 3521; authorisationCountryCode: SE
Maximum Dose
12 g per day
Investigational Product Name
Doktacillin 1g respektive 2 g pulver till injektions/infusionsvätska, lösning
Active Substance
AMPICILLIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
marketingAuthNumber: 7195; authorisationCountryCode: SE
Maximum Dose
12 g per day
Investigational Product Name
Cloxacillin Stragen 2 g pulver till injektions-/infusionsvätska, lösning
Active Substance
CLOXACILLIN SODIUM
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
marketingAuthNumber: 59080; authorisationCountryCode: SE
Maximum Dose
12 g per day
Investigational Product Name
Cefotaxim Stragen 1 g pulver till injektions- och infusionsvätska, lösning
Active Substance
CEFOTAXIME
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
marketingAuthNumber: 21298; authorisationCountryCode: SE
Maximum Dose
9 g per day
Investigational Product Name
Cubicin 350 mg powder for solution for injection or infusion
Active Substance
DAPTOMYCIN
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
marketingAuthNumber: EU/1/05/328/001; authorisationCountryCode: EU
Maximum Dose
700 mg per day (as listed)

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