EUCTR2016-003059-31-IT进行中（未招募）1 期
A Multicenter, Double-Blind, Randomized, Comparative Study of the Safety, Tolerability, Efficacy, and Pharmacokinetics of CF-301 vs. Placebo in Addition to Standard-of-Care Antibacterial Therapy for the Treatment of Adult Patients with Staphylococcus aureus Bloodstream Infections (Bacteremia) Including Right-Sided Endocarditis - Study to Assess the Efficacy, Safety and Pharmacokinetics of CF-301 Compared with Placebo in additio
CONTRAFECT CORPORATIO0 个研究点目标入组 115 人开始时间: 2021年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 115
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
- •male or female, 18 years or older.
- •blood culture positive for S. aureus.
- •at least one sign or symptom attributable to S. aureus bacteremia.
- •known or suspected right-sided endocarditis by Modified Duke Criteria and/or known or suspected complicated S. aureus BSI.
- •patient is not pregnant or breastfeeding and is not of reproductive potential or agrees to use contraception if of reproductive potential.
- •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 86
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 29
排除标准
- •patient previously received CF-301.
- •treatment with any potentially effective (anti-staphylococcal) systemic antibiotic for more than 72 hours within 7 days before randomization.
- •presence of any removable infection source that will not be removed or debrided within 72 hours after randomization.
- •presence of infected prosthetic joint or presence of cardiac device.
- •known or suspected left-sided endocarditis, brain abscess, osteomyelitis or meningitis.
- •pneumonia or known polymicrobial bacteremia.
- •patient is employed by the sponsor or investigational site or is a first degree relative of a person employed by the sponsor or investigational site. Patient is institutionalized by administrative or court order.
研究者
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