Cefadroxil for Staphylococcus aureus bacteremia

Inclusion criteria

• {"criterion_text":"- Adults aged 18 years and older\n- Ability to provide informed consent\n- Diagnose of SAB based on clinical (sign of any infections) and microbiological (blood cultures posi-tive for Staphylococcus aureus) criteria.\n- Clinical Improvement on initial intravenous antibiotic\n- At least one set of negative blood cultures - No signs of persistent bacteremia\n- Oral Tolerance - Ability to swallow and absorb oral medication - No suspicion of malabsorption\n- Timing - ≤ 7 days of first negative blood culture"}

Exclusion criteria

• {"criterion_text":"- Persistent bacteremia at inclusion time-point\n- Pregnancy or breastfeeding\n- Inability to receive oral medication or suspicion of malabsorption (gastrectomy or similar GI resec-tion / operation)\n- Allergy to beta-lactams or cephalosporin\n- In case of endocarditis, severe drug-drug interactions with Rifampin.\n- Patients should be randomized within 7 days from first negative blood culture\n- Polymicrobial infection\n- Staphylococcus aureus infection by an isolate which is not susceptible to cefadroxil\n- Hemodynamically instability at inclusion time point (systolic blood pressure < 100/mmHg, serum lactate> 2mmol/L; patient under noradrenaline drip)\n- Source control: In case of deep routed infection/prothesis infection and surgery indication, no performance of surgical source control due to patient’ health status or preferences. In case of catheter or intravascular device infections this should be removed before inclusion.\n- BMI > 40kg/m2\n- eGFR > 130ml/min or eGFR <25ml/min\n- Severe immunocompromised state (neutropenia (<500 neutrophils/μl); immunosuppressive combina-tion therapy with two or more drugs with different mode of action or biological therapy; solid organ transplantation; hematopoietic stem cell transplantation)"}

Primary endpoints

• {"endpoint_text":"- PK Assessment: Establishment of correct cefadroxil doses through Monte Carlo simulations (serum concentrations > MIC for at least 50% of the day). PD Assessment: Therapeutic failure will be assessed as a composite endpoint of relapsing SAB, deep-seated infection with the same bacteria, switch to another antimicrobial regimen due to ad-verse events or failure to improve, attributable rehospitalization, or attributable mortality within 90 days of inclusion. Adverse Events (AE): Monitoring and re","definition_or_measurement_approach":"PK: Monte Carlo simulations evaluating serum concentrations > MIC for at least 50% of the day. PD: composite endpoint defined as relapsing SAB, deep-seated infection with same bacteria, switch to another antimicrobial regimen due to adverse events or failure to improve, attributable rehospitalization, or attributable mortality within 90 days of inclusion. AE: monitoring (text truncated in source)."}

Belgium

Earliest CTIS Part Ii Submission Date

04-09-2025

Latest Decision Or Authorization Date

06-05-2026

Processing Time Days

244

Number Of Sites

1

Number Of Participants

25

Primary sponsor

Full Name

UZ Brussel

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium