A Phase 4 interventional study of Penicillin G_1200mg and cloxacillin in Staphylococcus Aureus Bacteraemia, Staphylococcal Bacteraemia and Staphylococcus Aureus Bloodstream Infections (BSI; Bacteremia), sponsored by Region Skane. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Region Skane · Phase 4, Interventional, and Treatment
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.
The overall research idea of is a RCT is to test the hypothesis that benzylpenicillin is superior to cloxacillin in the treatment of PSSA bacteraemia.
Population: Adult patients (>18 years) with PSSA bacteraemia will be eligible for enrolment in the study. Exclusion criteria are allergy to penicillin, inability to give informed consent, and concomitant growth of other clinically significant bacteria in blood cultures. We are planning a nation-wide study.
Intervention: Benzylpenicillin treatment of PSSA bacteraemia will be evaluated. As soon as S. aureus has been identified in blood cultures and the susceptibility testing indicates penicillin susceptibility (Two-three days from start of treatment), patients will be randomized to continue therapy with either cloxacillin or benzylpenicillin. The duration of treatment depends on the type of infection, and details about length of therapy and dosage will be decided by the specific patient diagnosis (i.e., endocarditis, arthritis). Repeated blood cultures and echocardiography are important in the diagnostic work-up of S. aureus bacteraemia and will be included in the study protocol. Patients will also be monitored regarding adverse events, such as liver and renal impairment, rash, diarrhoea, thrombophlebitis et c., and treatment failure, relapse, and mortality.
Control: The study drug (benzylpenicillin) will be compared to cloxacillin, which is the current drug of choice for methicillin susceptible S. aureus in Sweden. Both drugs will be used at clinically recommended doses, with appropriate adjustments for renal impairment if needed. Outcome: Primary outcome is; to be alive for 90 days without any complications. Complications are defined as having any of relapse (90 days after antibiotic finished), need of change or addition of antibiotics due to side effects or treatment failure or adverse events.
297 studies on the registry are indexed under Bacteremia; 51 are open to participants now.
This study's planned enrollment of 420 is above the median of 156 across 156 interventional studies indexed under Bacteremia.
Browse Bacteremia studies →Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Aged ≥18 with penicillin susceptible S. aureus bacteraemia (PSSA), and able to provide written .
Exclusion Criteria:
neutropenia
-≥ 96h with prior antibiotics
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Penicillin G_1200mg
Drug: cloxacillin
benzylpenicillin preferred dosing 1gx4
Also known as: bensylpenicillin, benzylpenicillin
cloxacillin 2gx4
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.
Time frame: From enrollment to 90 days after end of treatment
Mortality at 90 days
All cause mortality within 90 days from enrollment
Time frame: From enrollment to 90 days after end of treatment
Relapse 90 days after end of treatment
Relapse with positive culturing from sterile sites or high suscpition of clinical relapse
Time frame: From enrollment to 90 days after end of treatment
Cumulative frequency of side effects within 90 days
all side effects registered as a cumulative frequence
Time frame: From enrollment until 90 days.
Cumulative frequence of change or addition of antibiotic treatment due to sideeffects or treatment failure
Every time additional antibiotics or change in antibiotic treatment is made due to either side effects or treatment failure (according to treating doctor)
Time frame: from enrollment to end of treatment duration up to 90 days
Decrease of Bacterial DNA in blood samples
Bacterial DNA tested the first 5 days during study treatment.
Time frame: From enrollment and first 5 days
Days with intravenous antibiotics
Differences between treatment groups
Time frame: From enrollment and until end of treatment
Different outcome measures stratified by diagnosis
90 days mortality, relapse 90 days after end of treatment, cumulative side effects stratified by diagnosis
Time frame: From enrollment and up to 90 days after end of treatment
Plan to share: No — To share the IPD is not supported by the Swedish ethical comite.
Started Mar 2025 (actual). Primary completion is estimated for Apr 2028, 37 months after the start.
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Studies of the drug tested here: Penicillin G