Penicillin Against Flucloxacillin Treatment Evaluation
Status:
Unknown status
Trial end date:
2020-07-01
Target enrollment:
Participant gender:
Summary
There is theroretical superiority with benzylpenicillin over orther anti-staphylococcal
penicillins (ASP) for treatment of penicillin susceptible S. aureus (PSSA) infections due to
a lower MIC distribution when compared with ASPs active against PSSA, combined with the
ability to obtain higher levels of free non-protein-bound plasma drug concentrations.
Although the data to support this theoretical advantage is limited, many clinicians in
Australia (and worldwide) use benzylpenicillin for therapy in this situation despite many
international guidelines cautioning against this. This uncertainty is significant given that
1) S. aureus bacteraemia (SAB) is associated with a high mortality and significant morbidity,
2) S. aureus is one of the most common organisms isolated from blood cultures, 3) SAB is the
most common reason for consultation with an Infectious Disease specialist (which itself has
been shown to improve outcomes) and 4) a significant proportion (up to 20%) of SAB isolates
in Australia will be reported as susceptible to penicillin, a proportion which appears to be
increasing over the past 10 years in Australia and internationally.
Given the frequency of PSSA and the associated morbidity and mortality related to SABs in
general, a definitive study to determine the optimal therapy for PSSA is required. In a
recent survey of Infectious Diseases Physicians and Clinical Microbiologists in Australasia,
87% of respondents were willing to randomise patients to either benzylpenicillin or
flucloxacillin for a clinical trial, whist 71% responded that they would switch therapy from
flucloxacillin to benzylpenicillin for treatment of PSSA BSIs in clinical practice
(unpublished data).
Therefore, the investigators see the opportunity to determine the feasibility of a definitive
study comparing benzylpenicillin against flucloxacillin (or other ASP) for treatment of PSSA
bloodstream infections.
Phase:
Phase 4
Details
Lead Sponsor:
The University of Queensland
Treatments:
Floxacillin Penicillin G Penicillin G Benzathine Penicillin G Procaine Penicillins