Optimizing antibiotic treatment for complicated S. aureus infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot trial compares the effectiveness of continuous infusion of flucloxacillin or cefazolin, combined with therapeutic drug monitoring (TDM), against standard intermittent bolus administration in patients with complicated Staphylococcus aureus infections. The study aims to achieve optimal antibiotic plasma concentrations, particularly in critically ill patients who may have altered metabolism. By individualizing treatment based on real-time monitoring and dose adjustments, the trial seeks to improve patient outcomes and reduce mortality associated with these infections.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Informed Consent as documented by signature. For patients, who are not able to sign consent, a physician not involved in the current study has to confirm that patient's interest and rights are guaranteed during participation in the current study. Subsequently, informed consent will be obtained as soon as possible from the patient or his/her legally authorised representative.
* Age ≥ 18 years
* CSAI which is defined as (i) blood stream infection (BSI) with S. aureus or (ii) deep-seated infections caused by S. aureus (e.g. osteoarticular infections, deep-seated abscesses) without BSI.
* Intended or active (less than 24 hours) treatment with FLU or CZO

Exclusion Criteria:

* Patients on hemodialysis or eGFR\<10 ml/min as these patients have a special pharmacokinetic
* Patients on Cytosorb® therapy
* Patients with liver cirrhosis CHILD B and C
* Patients who are very likely to stop treatment with FLU or CZO in the next 48 hours as per treating physician (because of treatment failure, switch to oral medication, palliative care, allergy etc.) or who are very likely to be discharged or transferred to another hospital in the next 48 hours as per treating physician.
* Polymicrobial infection except concomitant isolation of a likely contaminant (e.g. Staphylococcus epidermidis or Cutibacterium acnes). If an additional pathogen is identified after inclusion of the patient into the study, the patient will remain in the study.
* CSAI caused by methicillin-resistant S. aureus (MRSA)
* Participation in another study with investigational drug within the 30 days preceding and during the present study
* Previous enrolment into the current study
* Any uncontrolled or significant concurrent illness that would put the patient at a greater risk or limit compliance with the study requirements at the discretion of the investigator

Where it's running

• University Hospital Basel, Division of Internal Medicine
  Basel, Switzerland Recruiting

Study contacts

• Principal investigator: Michael Osthoff, PD Dr. med. — University Hospital Basel, Division of Internal Medicine
• Study coordinator: Michael Osthoff, PD Dr. med.
• Email: michael.osthoff@usb.ch
• Phone: +41 61 328 54 20

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.