NCT03514446

Seven Versus Fourteen Days of Treatment in Uncomplicated Staphylococcus Aureus Bacteremia

Efficacy of Seven and Fourteen Days of Antibiotic Treatment in Uncomplicated Staphylococcus Aureus Bacteremia: A Randomized, Non-blinded, Non-inferiority Interventional Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 284 (estimated)
• Sponsor: Thomas Benfield · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Staphylococcus Aureus Bacteremia

Interventions

Type	Name	Description
DRUG	Antibiotic therapy duration for 7 days	Antibiotic therapy for seven days

Timeline

• Start date: 2018-06-01
• Primary completion: 2021-05-01
• Completion: 2021-11-01
• First posted: 2018-05-02
• Last updated: 2020-10-19

Locations

1 site across 1 country: Denmark

Regulatory

• FDA-regulated drug study