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

NCT06726395 | Recruiting Phase 4

• 1 other identifier: 2023-506860-15-00
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to investigate if benzylpenicillin is a better treatment option than cloxacillin in patients with penicillin-susceptible Staphylococcus aureus bacteraemia.

Conditions

Staphylococcus Aureus Bacteraemia; Staphylococcal Bacteraemia; Staphylococcus (S.) Aureus Infection; Staphylococcus Aureus Bloodstream Infections (BSI; Bacteremia)

Keywords

Penicillin treatment; benzylpenicillin; cloxacillin; Penicillin susceptible S. aureus; Staphylococcus aureus bacteraemia

Outcome Measures

Primary Outcomes (1)

• Survival at 90 days without any treatment complications

  Complications are defined as having any of; relapse within 90 days after treatment finish, need of change or addition of antibiotics due to side effects or treatment failure or adverse events.

  From enrollment to 90 days after end of treatment

Secondary Outcomes (5)

• Mortality at 90 days

  From enrollment to 90 days after end of treatment

• Relapse 90 days after end of treatment

  From enrollment to 90 days after end of treatment

• Cumulative frequency of side effects within 90 days

  From enrollment until 90 days.

• Cumulative frequence of change or addition of antibiotic treatment due to sideeffects or treatment failure

  from enrollment to end of treatment duration up to 90 days

• Decrease of Bacterial DNA in blood samples

  From enrollment and first 5 days

Other Outcomes (2)

• Days with intravenous antibiotics

  From enrollment and until end of treatment

• Different outcome measures stratified by diagnosis

  From enrollment and up to 90 days after end of treatment

Study Arms (2)

Benzylpenicillin treatment

EXPERIMENTAL

Drug: Penicillin G_1200mg

cloxacillin

ACTIVE COMPARATOR

Drug: cloxacillin

Interventions

Penicillin G_1200mg DRUG

benzylpenicillin preferred dosing 1gx4

Also known as: bensylpenicillin, benzylpenicillin

Benzylpenicillin treatment

cloxacillin DRUG

cloxacillin 2gx4

cloxacillin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 with penicillin susceptible S. aureus bacteraemia (PSSA), and able to provide written informed consent.

You may not qualify if:

• allergy to penicillin,
• inability to give informed consent,
• concomitant growth of other clinically significant bacteria in blood cultures
• neutropenia
• ≥ 96h with prior antibiotics
• When the per oral follow up medication can not be flukloxacillin or penicillinV/Amoxicillin (ie prosthetic joint infection)
• Patients in terminal palliation, where death is expected within 7 days.
• Where the treating physician believes cloxacillin is not a first-line treatment.

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Skånes universitetssjukhus, Region Skåne

Lund, 22467, Sweden

RECRUITING

Related Links

• CTIS

MeSH Terms

Conditions

Bacteremia

Interventions

Penicillin G; Cloxacillin

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Oxacillin

Study Officials

• Malin Hagstrand Aldman, PhD, MD

  Lund University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malin Hagstrand Aldman, PhD

CONTACT

+46768766308; malin.hagstrand-aldman@skane.se

Lisa I Påhlman, PhD, MD

CONTACT

Lisa.pahlman@med.lu.se

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Study personal assessing the side effects, are as fara as possible unaware of what study drug is given.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI, MD, PhD

Model Details: Observational

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 10, 2024
• Study Start: March 10, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)