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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Skane

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

allergy to penicillin,

inability to give informed consent,

concomitant growth of other clinically significant bacteria in blood cultures

neutropenia

Trial design

Design model

Parallel

Treatments tested in this trial

  • Penicillin G_1200mg

    Drug

    benzylpenicillin preferred dosing 1gx4

  • cloxacillin

    Drug

    cloxacillin 2gx4

Treatment groups

420 Participants
are divided into 2 treatment groups
Group A: Benzylpenicillin treatmentExperimental treatment 1 intervention
Group B: cloxacillinActive comparator 1 intervention

Trial outcomes

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.

Time frame
From enrollment to 90 days after end of treatment

Secondary outcomes

1

Mortality at 90 days

All cause mortality within 90 days from enrollment

Time frame
From enrollment to 90 days after end of treatment
2

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
3

Cumulative frequency of side effects within 90 days

all side effects registered as a cumulative frequence

Time frame
From enrollment until 90 days.
4

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

Other outcomes

1

Days with intravenous antibiotics

Differences between treatment groups

Time frame
From enrollment and until end of treatment
2

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

Sponsors and contacts

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