NCT05329168撤回2 期
An Open-Label, Multiple-Ascending Dose, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LSVT-1701 as an Add-on to Standard of Care Antibiotics for the Treatment of Complicated Methicillin-Sensitive and -Resistant Staphylococcus Aureus Bacteremia Including Left- and Right-sided Infective Endocarditis
Lysovant1 个研究点 分布在 1 个国家开始时间: 2022年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events coded per the Medical Dictionary of Regulatory Activities (MedDRA) v.24.0 [norm]
研究概览
简要总结
This study evaluates safety and tolerability of endolysin-derived LSVT-1701 (tonabacase) as an add-on to standard of care (SOC) antibiotic therapy for the treatment of patients with complicated Staphylococcus aureus bacteremia (SAB), including left- and right-sided infective endocarditis (IE).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 to 90 years
- •Index blood culture collection within 96 hours prior to enrollment positive for S. aureus
- •Experienced at least one sign or symptom related to SAB within past 96 hours prior to enrollment
- •Known or suspected left- and/or right-sided endocarditis by modified Duke criteria and/or known or suspected complicated SAB
- •Required duration of SOC antibiotic therapy ≤ 42 days
排除标准
- •Previous receipt of LSVT-1701 or CF-301 (exebacase)
- •Known hypersensitivity to kanamycin or other aminoglycosides
- •Treatment with any potentially effective (anti-S. aureus) systemic antibiotic for > 96 hours within 7 days before enrollment. Exception: Persistent S. aureus bacteremia after 96 hours of prior appropriate systemic antistaphylococcal antibiotic, and/or resistance to the prior systemic antibiotic
- •Treatment with dalbavancin or oritavancin within the previous 90 days
- •Known or suspected brain abscess or meningitis
- •Community acquired pneumonia, nosocomial pneumonia because of pathogens other than S. aureus, or known polymicrobial bacteremia
- •Presence of an intravascular infection source or extravascular material that cannot be removed within 96 hours after enrollment
研究组 & 干预措施
Sequential ascending-dose cohort
Experimental
Sequential ascending-dose cohort
干预措施: Tonabacase (LSVT-1701) (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events coded per the Medical Dictionary of Regulatory Activities (MedDRA) v.24.0 [norm]
时间窗: Up to Day 90±14
Incidence of Grade 3 or Grade 4 toxicity according to modified DAIDS criteria version 2.1
时间窗: Up to 14±4 days after end of SOC antibiotic therapy (up to Day 42)
Changes in 12-lead electrocardiogram (ECG)
时间窗: Day 1 and Day 2
次要结局
- Maximum plasma concentration (Cmax) of LSVT-1701(Day 4)
- Area under the concentration-time curve (AUC) of LSVT-1701(Day 4)
- Overall clinical response(Day 7, Day 14, after end of SOC antibiotic therapy (up to Day 42), and at test of cure (TOC; 14 days after the EOT))
- Microbiological response rate(Days 3, 5, 7, 14, and up to Day 90)
研究者
研究点 (1)
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