Clinical trial • Phase IV • Infectious Disease

CLOXACILLIN SODIUM for Staphylococcus aureus infection

Phase IV trial of CLOXACILLIN SODIUM for Staphylococcus aureus infection. 25 participants.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Staphylococcus aureus infection
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
03-06-2025
First CTIS Authorization Date
25-07-2025

Trial design

Phase IV trial across 1 site in Sweden.

Target Sample Size
25

Eligibility

Recruits 25 Mental incapacity, unwillingness, or language difficulties that result in difficulty understanding the implications of participating in the trial; Ability to provide written informed consent required; Vulnerable population not selected (isVulnerablePopulationSelected:false).

Pregnancy Exclusion
Known pregnancy
Vulnerable Population
Mental incapacity, unwillingness, or language difficulties that result in difficulty understanding the implications of participating in the trial; Ability to provide written informed consent required; Vulnerable population not selected (isVulnerablePopulationSelected:false)

Inclusion criteria

  • {"criterion_text":"- Age ≥18 years\n- Treating physician determines that the patient is suitable for transition from intermittent infusion to continuous infusion of cloxacillin (6-12g/24h) via elastomeric pump\n- Ability to provide written informed consent"}

Exclusion criteria

  • {"criterion_text":"- Mental incapacity, unwillingness, or language difficulties that result in difficulty understanding the implications of participating in the trial\n- Known pregnancy"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Concentration of total and free (unbound) cloxacillin at four time points; at the start of continuous infusion, 4h (±1h) after the start of continuous infusion, 24h (±1h) after the start of continuous infusion, and 48h (±1h) after the start of continuous infusion.","definition_or_measurement_approach":"Measurement of total and free (unbound) cloxacillin concentrations at four specified time points: at start of continuous infusion, 4h (±1h), 24h (±1h), and 48h (±1h) after start of continuous infusion."}

Recruitment

Registry Or Advocacy Recruitment
True, Projektdatabasen Region Västmanland (992496)
Planned Sample Size
25
Recruitment Window Months
26
Consent Approach
Ability to provide written informed consent required; Subject information and informed consent form available (L1_SIS and ICF); translations include Swedish.

Geography

Total Number Of Sites
1
Total Number Of Participants
25

Sweden

Earliest CTIS Part Ii Submission Date
09-06-2025
Latest Decision Or Authorization Date
25-07-2025
Processing Time Days
46
Number Of Sites
1
Number Of Participants
25

Sites

Site Name
Regionhuset
Department Name
Hälso- och sjukvårdsförvaltningen
Contact Person Name
Emeli Månsson

Sponsor

Primary sponsor

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

Investigational products

Investigational Product Name
Cloxacillin Stragen 2 g pulver till injektions-/infusionsvätska, lösning
Active Substance
CLOXACILLIN SODIUM
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised (marketing authorisation number 59080, authorisationCountryCode SE)
Starting Dose
6-12 g/24h
Frequency
Continuous infusion (24h)
Maximum Dose
12 g/24h

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