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Staphylococcus Aureus Bacteremia Antibiotic Treatment Options (SABATO)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University of Cologne.
Recruitment status was:  Recruiting
German Research Foundation
Information provided by (Responsible Party):
Gerd Fätkenheuer, University of Cologne Identifier:
First received: February 13, 2013
Last updated: December 2, 2014
Last verified: December 2014

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 [1]. 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 [2]. 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 Intervention Phase
Staphylococcus Aureus Infection
Drug: Trimethoprim-Sulfamethoxazole
Drug: Clindamycin
Drug: Linezolid
Drug: Flucloxacillin
Drug: Cloxacillin
Drug: Vancomycin
Drug: Daptomycin
Drug: Cefazolin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Oral Switch Therapy in Low-risk Staphylococcus Aureus Bloodstream Infection

Resource links provided by NLM:

Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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.

Other Outcome Measures:
  • Clostridium difficile associated diarrhea (CDAD) [ Time Frame: 90 days ]
    Clostridium difficile associated diarrhea (CDAD)

  • AEs and SAEs [ Time Frame: 90 days ]
    Adverse events

Estimated Enrollment: 430
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)
Arms Assigned Interventions
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
Drug: Trimethoprim-Sulfamethoxazole
study drug 1
Drug: Clindamycin
study drug 2
Drug: 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
Drug: Flucloxacillin
study drug 4
Drug: Cloxacillin
study drug 5
Drug: Vancomycin
study drug 6
Drug: Daptomycin
study drug 7
Drug: Cefazolin
study drug 8

Detailed Description:
  1. WHO. WHO Global Strategy for Containment of Antimicrobial Resistance.: World Health Organization, 2001.
  2. Kern WV. Management of Staphylococcus aureus bacteremia and endocarditis: progresses and challenges. Curr Opin Infect Dis 2010;23(4):346-58.
  3. 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.
  4. 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.
  5. 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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age at least 18 years
  • Not legally incapacitated
  • Written informed consent from the trial subject has been obtained
  • Blood culture positive for S. aureus
  • At least one negative follow-up blood culture obtained within 48-72 hours after the start of adequate therapy
  • Five to seven full days of appropriate i.v. antimicrobial therapy administered prior to randomization.

Exclusion Criteria:

  • Polymicrobial bloodstream infection
  • Recent history of prior S. aureus bloodstream infection
  • In vitro resistance of S. aureus to all oral or all i.v. study drugs
  • Contraindications for all oral or all i.v. study drugs
  • Signs and symptoms of complicated SAB as judged by an ID physician, such as deep-seated focus,septic shock, prolonged bacteremia, fever on two occasions within 48h before randomization,presence of non-removable foreign body.
  • Failure to remove (within 4 days) any intravascular catheter, which is present when first positive blood culture was drawn
  • Severe liver disease
  • End-stage renal disease
  • Severe immunodeficiency (e.g. primary immunodeficiency disorders, neutropenia CD4+ T-cell count <200/µl in HIV-positive patients, high-dose steroid therapy, recent hematopoietic stem cell transplantation, solid organ transplant)
  • "Do not resuscitate"-order or life expectancy < 3 months
  • Inability to take oral drugs
  • Injection drug user
  • Expected low compliance with drug regimen
  • Participation in other interventional trials
  • Pregnant women and nursing mothers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01792804

Contact: Achim J Kaasch, MD +4922147832100
Contact: Christian M Bernasch

Aachen Recruiting
Aachen, Germany, 52074
Principal Investigator: Sebastian Lemmen, Prof.Dr.         
Berlin Recruiting
Berlin, Germany, 12157
Principal Investigator: Keikawus Arastéh, PD Dr.         
Uniklinik Köln Recruiting
Cologne, Germany, 50935
Contact: Bernasch   
Principal Investigator: Gerd Fätkenheuer, Prof. Dr.         
Frankfurt Recruiting
Frankfurt/Main, Germany, 60590
Principal Investigator: Christoph Stephan, PD Dr.         
Freiburg Recruiting
Freiburg, Germany, 79106
Principal Investigator: Winfried V Kern, Prof. Dr.         
Hannover Recruiting
Hannover, Germany, 30625
Principal Investigator: Tobias Welte, Prof. Dr.         
Jena Recruiting
Jena, Germany, 07743
Principal Investigator: Matthias Pletz, Prof. Dr.         
Krefeld Recruiting
Krefeld, Germany, 47805
Principal Investigator: Katrin Kösters, Dr.         
Leverkusen Recruiting
Leverkusen, Germany, 51375
Principal Investigator: Stefan Reuter, PD Dr.         
Lübeck Recruiting
Lübeck, Germany, 23562
Principal Investigator: Jan Rupp, Prof. Dr.         
Regensburg Recruiting
Regensburg, Germany, 93053
Principal Investigator: Bernd Salzberger, Prof. Dr.         
Ulm Recruiting
Ulm, Germany, 89081
Principal Investigator: Georg Härtner, Dr.         
Amsterdam Recruiting
Amsterdam, Netherlands, 1105 AZ
Principal Investigator: Jan TM van der Meer, Prof. Dr.         
Breda Recruiting
Breda, Netherlands, 4814 CK Breda
Principal Investigator: Jan Kluytmans, Prof. Dr.         
Groningen Recruiting
Groningen, Netherlands, 9700 RB
Principal Investigator: Sander van Assen, Prof. Dr.         
Tilburg Recruiting
Tilburg, Netherlands, 5022GC
Principal Investigator: Jan Kluytmans, Prof. Dr.         
Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Principal Investigator: Marc Bonten, Prof. Dr.         
Barcelona II Recruiting
Barcelona, Spain, 08035
Principal Investigator: Benito Almirante, Prof. Dr.         
Barcelona I Recruiting
Barcelona, Spain, 08036
Principal Investigator: Alex Soriano, Prof. Dr.         
Sevilla II Recruiting
Sevilla, Spain, 41071
Principal Investigator: José Cisneros, Prof. Dr.         
Sevilla Recruiting
Sevilla, Spain, 41071
Principal Investigator: Jesus Rodríguez-Baño, Prof. Dr.         
United Kingdom
Nottingham Recruiting
Nottingham, United Kingdom, NG7 24 H
Principal Investigator: David Turner, Prof. Dr.         
Sponsors and Collaborators
University of Cologne
German Research Foundation
Study Chair: Achim J Kaasch, MD University of Cologne
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Gerd Fätkenheuer, Prof. Dr. med., University of Cologne Identifier: NCT01792804     History of Changes
Other Study ID Numbers: Uni-Koeln-1400  2013-000577-77 
Study First Received: February 13, 2013
Last Updated: December 2, 2014

Keywords provided by University of Cologne:
Staphylococcus aureus
Bloodstream infection
Oral switch

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Trimethoprim, Sulfamethoxazole Drug Combination
Clindamycin palmitate
Clindamycin phosphate
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Cytochrome P-450 CYP2C8 Inhibitors processed this record on February 24, 2017