Staphylococcus Aureus Bacteremia Antibiotic Treatment Options (SABATO)
Recruitment status was: Recruiting
Increasing resistance to antibiotic agents has been recognized as a major health problem worldwide that will even aggravate due to the lack of new antimicrobial agents within the next decade . This threat underscores the need to maximize clinical utility of existing antibiotics, through more rational prescription, e.g. optimizing duration of treatment.
Staphylococcus aureus bloodstream infection (SAB) is a common disease with about 200,000 cases occurring annually in Europe . A course of at least 14 days of intravenous antimicrobials is considered standard therapy [3-5] in "uncomplicated" SAB. This relatively long course serves to prevent SAB-related complications (such as endocarditis and vertebral osteomyelitis) that may result from hematogenous dissemination to distant sites. However, there is insufficient evidence that a full course of intravenous antibiotic therapy is always required in patients with a low risk of SAB-related complications.
In a multicenter, open-label, randomized controlled trial we aim to demonstrate that an early switch from intravenous to oral antimicrobial therapy is non-inferior to a conventional 14-days course of intravenous therapy regarding efficacy and safety. An early switch from intravenous to oral therapy would provide several benefits such as earlier discharge, fewer adverse reactions associated with intravenous therapy, increased quality of life, and cost savings.
Staphylococcus Aureus Infection
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Early Oral Switch Therapy in Low-risk Staphylococcus Aureus Bloodstream Infection|
- SAB-related complications [ Time Frame: 90 days ] [ Designated as safety issue: No ]S. aureus bloodstream infection-related complications (relapsing SAB, deep-seated infection with S. aureus, or attributable mortality) within 90 days
- Length of hospital stay [ Time Frame: 90 days ] [ Designated as safety issue: No ]Length of hospital stay
- Survival [ Time Frame: 14, 30, and 90 days ] [ Designated as safety issue: No ]Survival at 14, 30, and 90 days
- Complications of intravenous therapy [ Time Frame: 90 days ] [ Designated as safety issue: No ]Complications of intravenous therapy, such as thrombophlebitis.
- Clostridium difficile associated diarrhea (CDAD) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]Clostridium difficile associated diarrhea (CDAD)
- AEs and SAEs [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]Adverse events
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Orally administered antibiotic
First choice (MRSA and MSSA): trimethoprim-sulfamethoxazole, or Second choice (MSSA): clindamycin, or Second choice (MRSA): linezolid administered for 7-9 days
study drug 1Drug: Clindamycin
study drug 2Drug: Linezolid
study drug 3
Experimental: Intravenously administered antibiotic
First choice (MSSA): flucloxacillin [Spain: cloxacillin], or cefazolin or Second choice (MSSA): vancomycin, or First choice (MRSA): vancomycin, or Second choice (MRSA): daptomycin administered for 7-9 days
study drug 4Drug: Cloxacillin
study drug 5Drug: Vancomycin
study drug 6Drug: Daptomycin
study drug 7Drug: Cefazolin
study drug 8
- WHO. WHO Global Strategy for Containment of Antimicrobial Resistance.: World Health Organization, 2001.
- Kern WV. Management of Staphylococcus aureus bacteremia and endocarditis: progresses and challenges. Curr Opin Infect Dis 2010;23(4):346-58.
- Gemmell CG, Edwards DI, Fraise AP, Gould FK, Ridgway GL, Warren RE. Guidelines for the prophylaxis and treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections in the UK. J Antimicrob Chemother 2006;57(4):589-608.
- Liu C, Bayer A, Cosgrove SE, et al. Clinical practice guidelines by the Infectious Diseases Society of America for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis 2011;52(3):e18-55.
- Mermel LA, Allon M, Bouza E, et al. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis 2009;49(1):1-45.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01792804
|Aachen, Germany, 52074|
|Berlin, Germany, 12157|
|Cologne, Germany, 50935|
|Frankfurt/Main, Germany, 60590|
|Freiburg, Germany, 79106|
|Hannover, Germany, 30625|
|Jena, Germany, 07743|
|Krefeld, Germany, 47805|
|Leverkusen, Germany, 51375|
|Lübeck, Germany, 23562|
|Regensburg, Germany, 93053|
|Ulm, Germany, 89081|
|Amsterdam, Netherlands, 1105 AZ|
|Breda, Netherlands, 4814 CK Breda|
|Groningen, Netherlands, 9700 RB|
|Tilburg, Netherlands, 5022GC|
|Utrecht, Netherlands, 3584 CX|
|Barcelona, Spain, 08035|
|Barcelona, Spain, 08036|
|Sevilla, Spain, 41071|
|Sevilla, Spain, 41071|
|Nottingham, United Kingdom, NG7 24 H|
|Study Chair:||Achim J Kaasch, MD||University of Cologne|