Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05655091

Target Attainment of Continuous Infusion Flucloxacillin and Cefazolin Coupled With TDM vs. Standard of Care Treatment in Patients With Complicated S. Aureus Infection

Led by University Hospital, Basel, Switzerland · Updated on 2024-12-16

36

Participants Needed

1

Research Sites

109 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This prospective randomized, controlled interventional pilot trial, aims to compare the achievement of the optimal target concentration with continuously administered flucloxacillin (FLU) or cefazolin (CZO) coupled with TDM and subsequent dose adjustment versus standard of care (intermittent bolus application without TDM-guidance) in patients with complicated Staphylococcus aureus (S. aureus) infections (CSAI). The overall goal is to individualize and optimize antibiotic treatment in a very vulnerable group of patients overcoming the standard strategy of "one-dose-fits-all".

CONDITIONS

Official Title

Target Attainment of Continuous Infusion Flucloxacillin and Cefazolin Coupled With TDM vs. Standard of Care Treatment in Patients With Complicated S. Aureus Infection

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent or confirmation of patient rights by an independent physician if the patient cannot sign
  • Age 18 years or older
  • Complicated Staphylococcus aureus infection defined as bloodstream infection or deep-seated infection without bloodstream infection
  • Intended or active treatment with flucloxacillin or cefazolin started less than 24 hours ago
Not Eligible

You will not qualify if you...

  • Patients receiving hemodialysis or with estimated glomerular filtration rate (eGFR) less than 10 ml/min
  • Patients undergoing Cytosorb therapy
  • Patients with liver cirrhosis classified as Child B or Child C
  • Patients likely to stop flucloxacillin or cefazolin treatment within 48 hours due to treatment failure, switch to oral medication, palliative care, allergy, or expected discharge or transfer within 48 hours
  • Patients with polymicrobial infection except likely contaminants such as Staphylococcus epidermidis or Cutibacterium acnes
  • Patients with methicillin-resistant Staphylococcus aureus (MRSA) infection
  • Participation in another investigational drug study within 30 days before or during this study
  • Previous participation in this study
  • Any uncontrolled or significant concurrent illness that increases risk or limits study compliance as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospital Basel, Division of Internal Medicine

Basel, Switzerland, 4031

Actively Recruiting

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Research Team

M

Michael Osthoff, PD Dr. med.

CONTACT

S

Sarah Dräger, Dr. med.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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