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New treatment option for Complicated Staphylococcus Aureus (S. Aureus) Infections (CSAI)
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
ClinicalTrials.gov ID: NCT05655091
What this study is testing
What is FLU or CZO as continuous infusion?
FLU or CZO as continuous infusion is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for complicated staphylococcus aureus (s. aureus) infections (csai).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Intended or active (less than 24 hours) treatment with FLU or CZO
You likely can't join if
- 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...
- Polymicrobial infection except concomitant isolation of a likely contaminant (e.g. Staphylococcus epidermidis or Cutibacterium acnes). If an...
- CSAI caused by methicillin-resistant S. aureus (MRSA)
See the full eligibility 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...
- 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Basel, Switzerland
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basel, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.