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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
benzylpenicillin preferred dosing 1gx4
cloxacillin 2gx4
Skånes universitetssjukhus, Region Skåne
Lund, Sweden
RECRUITINGSurvival 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Enrollment
420