Staphylococcal InfectionsPhase 4KLONCNCT06848387
Unbound Cloxacillin Concentrations During Continuous Infusion
A Phase 4 study testing Unbound cloxacillin concentration in people with Staphylococcal Infections, run by Emeli Månsson at 1 site in Sweden.
Trial summary
Cloxacillin is the first-line choice for the treatment of severe infections caused by the bacterium Staphylococcus aureus in Sweden. Over the past year, cloxacillin is increasingly administred through continuous infusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staphylococcal Infections
- What is being tested?
- Unbound cloxacillin concentration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- 14 Jan 2026to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Treating physician has decided to start continuous infusion of cloxacillin
Who cannot join
- Unwilling or unable to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Karl-Johan Lindner, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Västmanlands sjukhus Västerås
Västerås
Emeli Månsson, PhD, 004621173000, emeli.mansson@regionvastmanland.se
About this study
Official title: Concentration of Unbound Cloxacillin in Adults Treated With Continuous Infusion Via Elastomeric Pump
Cloxacillin is the first-line choice for the treatment of severe infections caused by the bacterium Staphylococcus aureus in Sweden. Over the past year, cloxacillin is increasingly administred through continuous infusion. In this study, the free (unbound) concentration of cloxacillin when administered as a continuous infusion will be measured to ensure that the free concentration is neither too high nor too low. A PK/PD model will be developed to predict which dosage of cloxacillin is appropriate for an individual based on age, gender, kidney function, and serum-protein level.
- Conditions
- Staphylococcal Infections
- Being tested
- Unbound cloxacillin concentration
- Keywords
- cloxacillin
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unbound cloxacillin concentrationDiagnostic test
Unbound cloxacillin concentration measured at baseline, after 4h, after 24h and after 48h of continuous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with cloxacillin as continuous infusion via elastomeric pump | Experimental | Additional monitoring procedures performed: blood samples drawn before, after 4h, after 24h, and after 48h of continuous infusion of cloxacillin. Receives: Diagnostic Test: Unbound cloxacillin concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free (unbound) cloxacillin concentration
Measured: From enrollment to end of follow up at 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start14 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Low intervention trial according to Regulation (EU) No 536/2014. The investigational medical product - cloxacillin - is authorized and according to the protocol of the clinical trial 1. Cloxacillin is used in accordance with the terms of the marketing authorization 2. The use of cloxacillin is evidence-based 3. The additional monitoring procedures - four blood samples drawn before, after 4h, after 24h, and after 48h of continuous infusion of cloxacillin - do not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emeli Månsson
- Sponsor type
- University, hospital or other
- Collaborators
- Region Västmanland
- Responsible party
- Sponsor-investigator, Emeli Månsson, Region Västmanland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848387
- Sponsor's protocol ID
- 992496/KLONC
- Acronym
- KLONC
- Status last verified
- Feb 2026
- First submitted
- 15 Jan 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concentration of Unbound Cloxacillin in Adults Treated With Continuous Infusion Via Elastomeric Pump
- ClinicalTrials.gov ID
- NCT06848387
- Acronym / sponsor ID
- KLONC / 992496/KLONC
- Conditions
- Staphylococcal Infections
- Keywords
- cloxacillin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Emeli MånssonUniversity, hospital or other
- Collaborators
- Region Västmanland
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cloxacillin is the first-line choice for the treatment of severe infections caused by the bacterium Staphylococcus aureus in Sweden. Over the past year, cloxacillin is increasingly administred through continuous infusion. In this study, the free (unbound) concentration of cloxacillin when administered as a continuous infusion will be measured to ensure that the free concentration is neither too high nor too low. A PK/PD model will be developed to predict which dosage of cloxacillin is appropriate for an individual based on age, gender, kidney function, and serum-protein level.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Low intervention trial according to Regulation (EU) No 536/2014. The investigational medical product - cloxacillin - is authorized and according to the protocol of the clinical trial 1. Cloxacillin is used in accordance with the terms of the marketing authorization 2. The use of cloxacillin is evidence-based 3. The additional monitoring procedures - four blood samples drawn before, after 4h, after 24h, and after 48h of continuous infusion of cloxacillin - do not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice.
| Arm | Type | Receives |
|---|---|---|
| Treatment with cloxacillin as continuous infusion via elastomeric pump | Experimental | Diagnostic Test: Unbound cloxacillin concentrationAdditional monitoring procedures performed: blood samples drawn before, after 4h, after 24h, and after 48h of continuous infusion of cloxacillin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years or older
- Treating physician has decided to start continuous infusion of cloxacillin
Key exclusion criteria (1 listed)
- Unwilling or unable to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unbound cloxacillin concentrationUnbound cloxacillin concentration measured at baseline, after 4h, after 24h and after 48h of continuous infusion. | Diagnostic test | Treatment with cloxacillin as continuous infusion via elastomeric pump |
Primary outcome
Free (unbound) cloxacillin concentration
Time frame: From enrollment to end of follow up at 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karl-Johan Lindner, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Unbound cloxacillin concentration in people with Staphylococcal Infections, run by Emeli Månsson at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emeli Månsson, PhD (004621173000, emeli.mansson@regionvastmanland.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free (unbound) cloxacillin concentration (time frame: From enrollment to end of follow up at 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.