NL-OMON44940已完成3 期
EARLY ORAL SWITCH THERAPY IN LOW-RISK STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTION - SABATO: Staphylococcus aureus Bacteremia Antibiotic Treatment Options
niversity of Düsseldorf0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •> 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
排除标准
- •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
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