EUCTR2013-000577-77-DE进行中（未招募）1 期
EARLY ORAL SWITCH THERAPY IN LOW-RISK STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIONACRONYM: SABATO (Staphylococcus aureus Bacteremia Antibiotic Treatment Options) - SABATO
niversity of Düsseldorf0 个研究点目标入组 430 人开始时间: 2013年5月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 430
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- 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 24-96 hours after the start of adequate therapy
- •- Five to seven full days of appropriate i.v. antimicrobial therapy administered prior to randomization.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 290
排除标准
- •- 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 in reference documents 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 separate days within 48h before randomization
- •- Presence of a prosthetic heart valve, deep seated vascular graft with foreign material, ventriculo-atrial shunt
- •- Presence of prosthetic joint
- •- Presence of a pacemaker or an automated implantable cardioverter defibrillator device
- •- 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,uncontrolled disease in HIV positive patients, high-dose steroid therapy, hematopoietic stem cell transplantation within 6 months, solid organ transplant, treatment with biologicals)
- •- 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
- •- Persons with any kind of dependency on the investigator or employed by the sponsor or investigator
- •- For premenopausal women: Failure to use highly-effective contraceptive methods for 1 month after receiving study drug. The following contraceptive methods with a Pearl Index lower than 1% are regarded as highly-effective
- •- Persons held in an institution by legal or official order
研究者
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