Overview
Sponsor-declared trial summary
staphylococcus aureus bacteremia
To understand how the body processes and responds to the antibiotic cefadroxil by patients with a bloodstream infection caused by Staphylococcus aureus
Key facts
- Sponsor
- UZ Brussel
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 4 Jan 2026 → ongoing
- Decision date (initial)
- 2025-09-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacokinetic, Pharmacodynamic
To understand how the body processes and responds to the antibiotic cefadroxil by patients with a bloodstream infection caused by Staphylococcus aureus
Conditions and MedDRA coding
staphylococcus aureus bacteremia
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Adults aged 18 years and older
- Ability to provide informed consent
- Diagnose of SAB based on clinical (sign of any infections) and microbiological (blood cultures posi-tive for Staphylococcus aureus) criteria.
- Clinical Improvement on initial intravenous antibiotic
- At least one set of negative blood cultures - No signs of persistent bacteremia
- Oral Tolerance - Ability to swallow and absorb oral medication - No suspicion of malabsorption
- Timing - ≤ 7 days of first negative blood culture
Exclusion criteria 13
- Persistent bacteremia at inclusion time-point
- Patients should be randomized within 7 days from first negative blood culture
- Polymicrobial infection
- Staphylococcus aureus infection by an isolate which is not susceptible to cefadroxil
- Hemodynamically instability at inclusion time point (systolic blood pressure < 100/mmHg, serum lactate> 2mmol/L; patient under noradrenaline drip)
- 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.
- BMI > 40kg/m2
- eGFR > 130ml/min or eGFR <25ml/min
- 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)
- Pregnancy or breastfeeding
- Inability to receive oral medication or suspicion of malabsorption (gastrectomy or similar GI resec-tion / operation)
- Allergy to beta-lactams or cephalosporin
- In case of endocarditis, severe drug-drug interactions with Rifampin.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Cefadroxil Sandoz 500 mg harde capsules
PRD753883 · Product
- Active substance
- Cefadroxil
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 4 g gram(s)
- Max total dose
- 2 g gram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01DB05 — -
- Marketing authorisation
- BE240527
- MA holder
- SANDOZ N.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
UZ Brussel
- Sponsor organisation
- UZ Brussel
- Address
- Laarbeeklaan 101
- City
- Jette
- Postcode
- 1090
- Country
- Belgium
Scientific contact point
- Organisation
- UZ Brussel
- Contact name
- Marco Moretti
Public contact point
- Organisation
- UZ Brussel
- Contact name
- Alex De Waele
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruiting | 25 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2026-01-04 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-522547-17-00 | 3 |
| Recruitment arrangements (for publication) | K1_Recruitement arrangements | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF NL | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF ENG | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF FR | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Cefadroxil NL | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis ENG 2025-522547-17-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis FR 2025-522547-17-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis GER 2025-522547-17-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis NL 2025-522547-17-00 | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-07 | Belgium | Acceptable 2025-09-24
|
2025-09-24 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-06 | Belgium | Acceptable 2025-09-24
|
2026-05-06 |