Staphylococcus Aureus Bacteremia Antibiotic Treatment Options (SABATO)
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|ClinicalTrials.gov Identifier: NCT01792804|
Recruitment Status : Recruiting
First Posted : February 15, 2013
Last Update Posted : March 2, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Staphylococcus Aureus Infection||Drug: Trimethoprim-Sulfamethoxazole Drug: Clindamycin Drug: Linezolid Drug: Flucloxacillin Drug: Cloxacillin Drug: Vancomycin Drug: Daptomycin Drug: Cefazolin||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||430 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Oral Switch Therapy in Low-risk Staphylococcus Aureus Bloodstream Infection|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
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
- SAB-related complications [ Time Frame: 90 days ]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 ]Length of hospital stay
- Survival [ Time Frame: 14, 30, and 90 days ]Survival at 14, 30, and 90 days
- Complications of intravenous therapy [ Time Frame: 90 days ]Complications of intravenous therapy, such as thrombophlebitis.
- Clostridium difficile associated diarrhea (CDAD) [ Time Frame: 90 days ]Clostridium difficile associated diarrhea (CDAD)
- AEs and SAEs [ Time Frame: 90 days ]Adverse events
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792804
|Contact: Achim J Kaasch, MDemail@example.com|
|Contact: Anna Rommerskirchenfirstname.lastname@example.org|
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|Principal Investigator:||Achim J Kaasch, MD||Heinrich-Heine University, Duesseldorf|