Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID06726395

Randomized Controlled Trial Comparing Benzylpenicillin and Cloxacillin for Penicillin-Susceptible Staphylococcus Aureus Bacteraemia

Led by Region Skane · Updated on 2026-04-30

420

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether benzylpenicillin is a better treatment than cloxacillin for adults with penicillin-susceptible Staphylococcus aureus bacteraemia (PSSA). This randomized controlled trial aims to compare these two antibiotics to see which leads to better outcomes, such as survival without complications, in patients with this bloodstream infection. The study is planned as a nation-wide effort involving adult patients over 18 years old. Participants will be randomly assigned to receive either benzylpenicillin or cloxacillin after confirming penicillin susceptibility of the bacteria from blood cultures, which typically takes two to three days. The dosage and treatment length depend on the specific infection diagnosis, such as endocarditis or arthritis. Both drugs will be given at recommended doses adjusted for kidney function when needed. The study includes repeated blood cultures and heart ultrasounds as part of the evaluation process to monitor infection and treatment effects. During the study, participants will be closely monitored for side effects like liver or kidney problems, rash, diarrhea, and blood vessel inflammation, as well as treatment failure, relapse, and survival over 90 days after treatment ends. Researchers will assess survival without complications, relapse rates, antibiotic changes due to side effects or treatment failure, and bacterial DNA levels in blood samples during the first five days. The total participation time covers treatment and follow-up for 90 days to evaluate outcomes and safety.

CONDITIONS

Brief Title

Comparison of Cloxacillin and Benzylpenicillin in Penicillin Susceptible S. Aureus Bacteraemia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older with penicillin-susceptible Staphylococcus aureus bacteraemia
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Allergy to penicillin
  • Unable to provide informed consent
  • Presence of other clinically significant bacteria in blood cultures
  • Neutropenia
  • Prior antibiotic treatment for 96 hours or more
  • Inability to use oral follow-up medication with flucloxacillin or penicillin V/Amoxicillin (e.g., prosthetic joint infection)
  • Terminal palliative care with expected death within 7 days
  • Treating physician believes cloxacillin is not a first-line treatment

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Varies depending on infection type and treatment response

Participants receive either benzylpenicillin or cloxacillin treatment for penicillin-susceptible Staphylococcus aureus bacteraemia. The treatment duration depends on the specific infection diagnosis and clinical decisions.

Visits occur as needed for treatment monitoring and follow-up

Follow-up

Duration - Up to 90 days after end of treatment

Participants are monitored for up to 90 days after the end of treatment for survival without complications, relapse, side effects, and treatment failure.

Follow-up visits and assessments during the 90-day post-treatment period

Trial Site Locations

Total: 1 location

1

Skånes universitetssjukhus, Region Skåne

Lund, Sweden, 22467

Actively Recruiting

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Research Team

M

Malin Hagstrand Aldman, PhD

L

Lisa I Påhlman, PhD, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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