Seven Versus Fourteen Days of Treatment in Uncomplicated Staphylococcus Aureus Bacteremia
Status:
Recruiting
Trial end date:
2021-11-01
Target enrollment:
Participant gender:
Summary
Introduction: Staphylococcus aureus bacteremia (SAB) plays an important role in long-course
antibiotic therapy. Current international guidelines recommend fourteen days of intravenous
antibiotic treatment for SAB in order to minimize risks of secondary deep infections and
complications. However, patients with simple SAB are known to have a low risk of
complications. Reducing treatment length in uncomplicated SAB would reduce the total
consumption of antibiotics, adverse events and duration of hospital admission. SAB7 seeks to
determine if seven days of antibiotic treatment in patients with uncomplicated SAB is
non-inferior to fourteen days of treatment.
Method: The study is designed as a randomized, non-blinded, non-inferiority interventional
study. Primary measure of outcome will be failure to treatment or recurrence of SAB twelve
weeks after termination of antibiotic treatment. As a measure of secondary outcome the
prevalence of severe adverse effects will be evaluated, in particular secondary infection
with Clostridium difficile, mortality as well as public health related costs. Patients
identified with uncomplicated SAB, are randomized 1:1 in two parallel arms to seven or
fourteen days of antimicrobial treatment, respectively. Endpoints will be tested with a
statistical non-inferiority margin of 10%.
Conclusion: SAB 7 will determine if seven days of antibiotic treatment in patients with
uncomplicated SAB is sufficient and safe, potentially modifying current treatment
recommendations.