EARLY ORAL SWITCH THERAPY IN LOW-RISK STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIO
- Conditions
- bacterial infectionresistant bacteria10004018
- Registration Number
- NL-OMON44940
- Lead Sponsor
- niversity of Düsseldorf
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
> 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
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.
• Severe liver disease. This is not an exclusion criterion, if the following condition is fulfilled:
catheter-related infection, skin and soft tissue infection or surgical wound infection is present.
End-stage renal disease. This is not an exclusion criterion, if all of the following conditions are fulfilled: 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 in patients with a hemodialysis shunt with a non-removable foreign body (e.g. synthetic PTFE loop): no clinical signs of a shunt infection
Severe immunodeficiency (e.g. neutropenia, high dose steroid therapy, immonusuppresive combination therapy, biological (last year), hematopoietic stem cell transplant, solid organ transplant)
Life expectancy < 3 months
Inability to take oral drugs
Expected low compliance with drug regimen
Participation in other interventional trials
Pregnancy/nursing
For included women: Failure to use highly-effective contraceptive methods
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method