Seven Versus Fourteen Days of Treatment in Uncomplicated Staphylococcus Aureus Bacteremia

Last updated: October 14, 2020
Sponsor: Thomas Benfield
Overall Status: Active - Recruiting

Phase

4

Condition

Sepsis And Septicemia

Soft Tissue Infections

Treatment

N/A

Clinical Study ID

NCT03514446
H-17027414
2017-003529-13
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age > 18 years

  • Blood culture positive for Staphylococcus aureus

  • Antibiotic treatment with antimicrobial activity to S. aureus administrated within 12hours of the first positive blood culture

  • Temperature < 37,5 degrees celsius at randomization

  • S. aureus negative follow-up blood culture obtained 48-96 hours after microbiologicalverified SAB.

  • Patients written consent obtained

Exclusion

Exclusion Criteria:

  • Persistence of S. aureus bacteremia before randomization (S. aureus positive follow-upblood culture obtained 48-96 hours of the first positive blood culture)

  • Polymicrobial infection

  • Antibiotic treatment whit no antimicrobial activity to S. aureus administrated morethan 12 hours of the first positive blood culture

  • Endocarditis or other intracardiac infection demonstrated with transthoracic ortransesophageal echocardiography

  • Previous history of endocarditis

  • Pacemaker or other intracardiac implant

  • Failure to remove a likely focus of infection, such as central venous catheter within 72 hours of the first positive blood culture.

  • Prosthetics in joints and bones or vascular grafts

  • Pneumonia or infection involving bone or joints

  • Previously bone/join infection

  • S. aureus infection within the last 90 days

  • Pregnancy or breastfeeding

  • Neutropenia (blood neutrophils < 1,0 x 109/l)

  • Untreated cancer

  • Chemotherapy within 90 days.

Study Design

Total Participants: 284
Study Start date:
June 01, 2018
Estimated Completion Date:
November 01, 2021

Connect with a study center

  • Hvidovre Hospital

    Hvidovre, Copenhagen 2650
    Denmark

    Active - Recruiting

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