Optimizing antibiotic treatment for complicated S. aureus infections
Can Continuous Infusion Coupled With Therapeutic Drug Monitoring Optimize Flucloxacillin and Cefazolin Target Attainment Compared to Standard Intermittent Bolus Dosing in Patients With Complicated Staphylococcus Aureus Infections? A Randomized, Controlled Interventional Pilot Trial.
This study is testing whether a new way of giving antibiotics continuously, with careful monitoring, can help critically ill patients with complicated Staphylococcus aureus infections feel better and recover faster than the usual method.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Trial ID | NCT05655091 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with complicated S. aureus infections requiring treatment with flucloxacillin or cefazolin.
Not a fit: Patients on hemodialysis, with severe liver cirrhosis, or those unlikely to continue treatment within 48 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective treatment of complicated S. aureus infections, potentially reducing mortality rates.
How similar studies have performed: While the use of TDM in antibiotic therapy is gaining traction, this specific approach of continuous infusion coupled with TDM is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Basel
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.