Increasing resistance to antibiotic agents has been recognized as a major health problem
worldwide that will even aggravate due to the lack of new antimicrobial agents within the
next decade [1]. This threat underscores the need to maximize clinical utility of existing
antibiotics, through more rational prescription, e.g. optimizing duration of treatment.
Staphylococcus aureus bloodstream infection (SAB) is a common disease with about 200,000
cases occurring annually in Europe [2]. A course of at least 14 days of intravenous
antimicrobials is considered standard therapy [3-5] in "uncomplicated" SAB. This relatively
long course serves to prevent SAB-related complications (such as endocarditis and vertebral
osteomyelitis) that may result from hematogenous dissemination to distant sites. However,
there is insufficient evidence that a full course of intravenous antibiotic therapy is always
required in patients with a low risk of SAB-related complications.
In a multicenter, open-label, randomized controlled trial we aim to demonstrate that an early
switch from intravenous to oral antimicrobial therapy is non-inferior to a conventional
14-days course of intravenous therapy regarding efficacy and safety. An early switch from
intravenous to oral therapy would provide several benefits such as earlier discharge, fewer
adverse reactions associated with intravenous therapy, increased quality of life, and cost
savings.
Phase:
Phase 3
Details
Lead Sponsor:
Heinrich-Heine University, Duesseldorf University of Cologne