Seven Versus Fourteen Days of Treatment in Uncomplicated Staphylococcus Aureus Bacteremia (SAB7)
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|ClinicalTrials.gov Identifier: NCT03514446|
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : July 24, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Staphylococcus Aureus Bacteremia||Drug: Antibiotic therapy duration for 7 days||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||284 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficacy of Seven and Fourteen Days of Antibiotic Treatment in Uncomplicated Staphylococcus Aureus Bacteremia: A Randomized, Non-blinded, Non-inferiority Interventional Study|
|Actual Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||May 1, 2021|
|Estimated Study Completion Date :||November 1, 2021|
|Experimental: Antibiotic therapy duration for 7 days||
Drug: Antibiotic therapy duration for 7 days
Antibiotic therapy for seven days
|No Intervention: Antibiotic therapy duration for 14 days|
- 90-day survival without clinical or microbiological failure to treatment or relapse [ Time Frame: up to 90 days ]
- Microbiologically failure to treatment [ Time Frame: less than 7 days after treatment termination ]Verified S. aureus infection of the same genotype as the initial infection
- Microbiologically relapse [ Time Frame: more than 7 days after treatment termination ]Verified S. aureus infection of the same genotype as the initial infection
- Clinical failure to treatment or relapse [ Time Frame: Up to day 90 ]Initiation of anti-staphylococcal therapy for more than 48 hours due to suspected recurrence.
- Mortality [ Time Frame: Days 14, 28, 90 and 180 ]All-cause mortality
- Severe adverse events [ Time Frame: Up to 26 weeks ]grade 3 or above adverse events
- Acute renal injury [ Time Frame: Up to 26 weeks ]A 1.5 fold increase in creatinine or a 25% decrease of the glomerular filtration rate (GFR)
- Clostridium difficile infection [ Time Frame: Up to 26 weeks ]Microbiologically verified C. difficile infection
- Multidrug-resistance organism [ Time Frame: Up to 26 weeks ]Microbiologically verified multidrug-resistance organism
- Health-associated costs [ Time Frame: Up to 26 weeks ]Public health related cost estimated from a general consideration of the expenses associated with hospitalization for SAB.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514446
|Contact: Louise Thorlacius-Ussing, MD||+45 firstname.lastname@example.org|
|Contact: Thomas Benfield, MD, DMSc||Thomas.Lars.Benfield@regionh.dk|
|Hvidovre, Copenhagen, Denmark, 2650|
|Contact: Louise Ussing, MD 26457710 email@example.com|