Seven Versus Fourteen Days of Treatment in Uncomplicated Staphylococcus Aureus Bacteremia (SAB7)

Thomas Benfield

Status and phase

Unknown

Phase 4

Conditions

Staphylococcus Aureus Bacteremia

Treatments

Drug: Antibiotic therapy duration for 7 days

Study type

Interventional

Funder types

Other

Identifiers

NCT03514446

2017-003529-13 (EudraCT Number)

H-17027414

Details and patient eligibility

About

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.

Enrollment

284 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age > 18 years
Blood culture positive for Staphylococcus aureus
Antibiotic treatment with antimicrobial activity to S. aureus administrated within 12 hours 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 microbiological verified SAB.
Patients written consent obtained

Exclusion criteria

Persistence of S. aureus bacteremia before randomization (S. aureus positive follow-up blood culture obtained 48-96 hours of the first positive blood culture)
Polymicrobial infection
Antibiotic treatment whit no antimicrobial activity to S. aureus administrated more than 12 hours of the first positive blood culture
Endocarditis or other intracardiac infection demonstrated with transthoracic or transesophageal 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.