NL-OMON44940
Completed
Phase 3
EARLY ORAL SWITCH THERAPY IN LOW-RISK STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTION - SABATO: Staphylococcus aureus Bacteremia Antibiotic Treatment Options
niversity of Düsseldorf0 sites60 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- bacterial infection
- Sponsor
- niversity of Düsseldorf
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •\> 18 years, not legally incapacitated, written consent, blood culture positive for S. aureus not considered to represent contamination
- •Negative follow\-up blood culture within 24\-96 hours after start of adequate antimicrobial therapy
- •5\-7 full days of appropiate i.v. antimicrobial therapy prior to randomization
Exclusion Criteria
- •Polymicrobial bloodstream infection
- •Recent history of prior SAB (within 3 months)
- •In vitro resistance of S.aureus to all oral or all i.v. drugs
- •Previously planned treatment with active drug against S. aureus during intervention phase (e.g. cotrimoxazol prohylaxis)
- •Signs and symptoms of complicated SAB (deep\-seated focus, septic shock within 4 d, prolonged bacteremia, fever(\>38C) twice within 48h before randomization
- •Presence of the following non\-removable foreign bodies (if not removed 2 days or more before randomization): prosthetic heart valve, ascular graft, ventriculo\-atrial shunt
- •Presence of a prosthetic joint (if not removed 2 days or more before randomization). This is not an exclusion criterion, if all of the following conditions are fulfilled:prosthetic joint was implanted at least 6 months prior and catheter\-related infection, skin and soft tissue infection or surgical wound infection is present and joint infection unlikely (no clinical or imaging signs)
- •Presence of a pacemaker or an automated implantable cardioverter defibrillator (AICD) device (if not removed 2 days or more before randomization). This is not an exclusion criterion, if all of the following conditions are fulfilled: pacemaker or AICD was implanted at least 6 months prior, and
- •catheter\-related infection, skin and soft tissue infection or surgical wound infection is present and no clinical signs of infective endocarditis, and infective endocarditis unlikely by echocardiography (preferably TEE), and pocket infection unlikely (no clinical or imaging signs)
- •Failure to remove any intravascular catheter which is present when first positive blood culture was drawn within 4 days of the first positive blood culture.
Outcomes
Primary Outcomes
Not specified
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