Overview
Sponsor-declared trial summary
Staphylococcus aureus infection
The purpose of the study is to verify that continuous infusion of cloxacillin via an elastomeric pump provides an adequate concentration of free cloxacillin, and that patients are not at risk of neither toxic nor inadequate levels.
Key facts
- Sponsor
- Region Vaestmanland
- 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
- 12 Dec 2025 → ongoing
- Decision date (initial)
- 2025-07-25
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Region Västmanland
External identifiers
- EU CT number
- 2023-510423-30-00
- ClinicalTrials.gov
- NCT06848387
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic
The purpose of the study is to verify that continuous infusion of cloxacillin via an elastomeric pump provides an adequate concentration of free cloxacillin, and that patients are not at risk of neither toxic nor inadequate levels.
Conditions and MedDRA coding
Staphylococcus aureus infection
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Age ≥18 years
- Treating physician determines that the patient is suitable for transition from intermittent infusion to continuous infusion of cloxacillin (6-12g/24h) via elastomeric pump
- Ability to provide written informed consent
Exclusion criteria 2
- Mental incapacity, unwillingness, or language difficulties that result in difficulty understanding the implications of participating in the trial
- Known pregnancy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Concentration of total and free (unbound) cloxacillin at four time points; at the start of continuous infusion, 4h (±1h) after the start of continuous infusion, 24h (±1h) after the start of continuous infusion, and 48h (±1h) after the start of continuous infusion.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Cloxacillin Stragen 2 g pulver till injektions-/infusionsvätska, lösning
PRD9285368 · Product
- Active substance
- Cloxacillin Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 12 g gram(s)
- Max total dose
- 504 g gram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01CF02 — CLOXACILLIN
- Marketing authorisation
- 59080
- MA holder
- STRAGEN NORDIC A/S
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Vaestmanland
- Sponsor organisation
- Region Vaestmanland
- Address
- Regionhuset
- City
- Vasteras
- Postcode
- 721 89
- Country
- Sweden
Scientific contact point
- Organisation
- Region Vaestmanland
- Contact name
- CIFU Forskning
Public contact point
- Organisation
- Region Vaestmanland
- Contact name
- Kontaktcenter
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, 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 |
|---|---|---|---|---|---|
| Sweden | 2025-12-12 | 2026-01-14 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023 510423 30 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Cloxacillin | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis Sv 2023 510423 30 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-03 | Sweden | Acceptable 2025-07-25
|
2025-07-25 |