NCT03514446: SAB7

Seven Versus Fourteen Days of Treatment in Uncomplicated Staphylococcus Aureus Bacteremia

Status unknown Phase 4 Last updated 19 October 2020

What this trial tests

Phase 4 trial testing Antibiotic therapy duration for 7 days in Staphylococcus Aureus Bacteremia in 284 participants. Status unknown.

Timeline

1 June 2018

Primary endpoint
1 May 2021

1 November 2021

Quick facts

Lead sponsor	Thomas Benfield
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	284
Start date	1 June 2018
Primary completion	1 May 2021
Estimated completion	1 November 2021
Sites	1 location across Denmark

Drugs / interventions tested

• Antibiotic therapy duration for 7 days — full drug profile →

Conditions studied

• Staphylococcus Aureus Bacteremia — all drugs for Staphylococcus Aureus Bacteremia →

Sponsor

Thomas Benfield — full company profile →

Who can join

18 and older, any sex, with Staphylococcus Aureus Bacteremia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antibiotic stewardship in the ICU: time to shift into overdrive.
   Mokrani D, Chommeloux J, Pineton de Chambrun M, Hékimian G, et al · · 2023 · cited 38× · PMID 37148398 · DOI 10.1186/s13613-023-01134-9
2. Short-term <i>versus</i> usual-term antibiotic treatment for uncomplicated <i>Staphylococcus aureus</i> bacteremia: a systematic review and meta-analysis.
   Grillo Perez S, Diaz-Brochero C, Garzon Herazo JR, Muñoz Velandia OM. · · 2024 · cited 2× · PMID 38476737 · DOI 10.1177/20499361241237615