EUCTR2016-003059-31-ES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
ContraFect Corporation0 个研究点目标入组 115 人开始时间: 2017年10月16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
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 48 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 prosthetic joint or 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.
研究者
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Study to Assess the Efficacy, Safety and Pharmacokinetics of CF-301 Compared with Placebo in addition to Standard-of-Care antibiotic therapy in Blood Infections caused by S. aureus, including heart valve infectionsS. aureus bloodstream infectionsMedDRA version: 20.0 Level: PT Classification code 10014665 Term: Endocarditis System Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0 Level: LLT Classification code 10077008 Term: Methicillin-sensitive Staphylococcus aureus infection System Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1 Level: LLT Classification code 10041937 Term: Staphylococcus aureus endocarditis System Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0 Level: LLT Classification code 10021839 Term: Infection MRSA System Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0 Level: LLT Classification code 10054637 Term: Staphylococcal bacteremia System Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1 Level: PT Classification code 10003997 Term: Bacteraemia System Organ Class: 10021881 - Infections and infestationsEUCTR2016-003059-31-BEContraFect Corporation115
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Study to Assess the Efficacy, Safety and Pharmacokinetics of CF-301 Compared with Placebo in addition to Standard-of-Care antibiotic therapy in Blood Infections caused by S. aureus, including heart valve infectionsS. aureus bloodstream infectionsMedDRA version: 20.0Level: PTClassification code 10014665Term: EndocarditisSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0Level: LLTClassification code 10077008Term: Methicillin-sensitive Staphylococcus aureus infectionSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1Level: PTClassification code 10003997Term: BacteraemiaSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1Level: LLTClassification code 10041937Term: Staphylococcus aureus endocarditisSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0Level: LLTClassification code 10021839Term: Infection MRSASystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0Level: LLTClassification code 10054637Term: Staphylococcal bacteremiaSystem Organ Class: 10021881 - Infections and infestationsEUCTR2016-003059-31-GRContraFect Corporation115
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不适用
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