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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
284
Antibiotic therapy for seven days
Hvidovre Hospital
Hvidovre, Copenhagen, Denmark
RECRUITING90-day survival without clinical or microbiological failure to treatment or relapse
Time frame: up to 90 days
Microbiologically failure to treatment
Verified S. aureus infection of the same genotype as the initial infection
Time frame: less than 7 days after treatment termination
Microbiologically relapse
Verified S. aureus infection of the same genotype as the initial infection
Time frame: more than 7 days after treatment termination
Clinical failure to treatment or relapse
Initiation of anti-staphylococcal therapy for more than 48 hours due to suspected recurrence.
Time frame: Up to day 90
Mortality
All-cause mortality
Time frame: Days 14, 28, 90 and 180
Severe adverse events
grade 3 or above adverse events
Time frame: Up to 26 weeks
Acute renal injury
A 1.5 fold increase in creatinine or a 25% decrease of the glomerular filtration rate (GFR)
Time frame: Up to 26 weeks
Clostridium difficile infection
Microbiologically verified C. difficile infection
Time frame: Up to 26 weeks
Multidrug-resistance organism
Microbiologically verified multidrug-resistance organism
Time frame: Up to 26 weeks
Health-associated costs
Public health related cost estimated from a general consideration of the expenses associated with hospitalization for SAB.
Time frame: Up to 26 weeks
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