Phase 2a, Repeated-dose, Open-label, Single-arm Study of CG400549 for the Treatment of Complicated Acute Bacterial Skin and Skin Structure Infection (cABSSSI) Caused by Methicillin-resistant Staphylococcus Aureus (MRSA)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Status of Subject's Clinical Responses
研究概览
简要总结
Primary Objective:
To make a preliminary assessment of the efficacy of CG400549 (960 mg daily) in subjects with cABSSSI (major cutaneous abscesses) due to MRSA.
Secondary Objective(s):
- To assess the pharmacokinetics of CG400549 (960 mg daily) in subjects with cABSSSI due to MRSA
- To explore the in vitro susceptibility of cABSSSI-related bacteria to CG400549.
- To assess the safety of multiple doses of CG400459
详细描述
This will be an open-label, exploratory study to evaluate the safety, pharmacokinetics, and efficacy of CG400549, daily for 10 to 14 days, in subjects with cABSSSI (major cutaneous abscesses) due to MRSA. All subjects will receive active treatment.
Subjects will begin study treatment upon confirmation of clinical eligibility (ie, confirmation of MRSA infection is not required pretreatment). Subjects who begin treatment with CG400549 and are subsequently not found to have S. aureus infection will be discontinued from study treatment, treated as appropriate for the identified pathogen(s), and followed for safety. These subjects will be included in the safety analyses but not in the primary efficacy analysis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of major cutaneous abscess suspected or confirmed to be caused by a MRSA.
- •Signs and symptoms should include at least 2 of the following: purulent drainage or discharge, erythema, fluctuance, heat or localized warmth, edema/induration, pain or tenderness to palpation
排除标准
- •Prior systemic or topical antibacterial therapy
- •Severe sepsis or refractory shock
研究组 & 干预措施
Single Arm for CG400549
All the patients will be administered with CG400549.
干预措施: CG400549 (Drug)
结局指标
主要结局
Status of Subject's Clinical Responses
时间窗: Early Clinical Evaluation (ECE, 48 to 72 hours after enrollment)
Stable/improving infection, as defined by the Investigator assessment, was defined as cessation of the spread of the redness, edema, and/or induration of the lesion or reduction in the size (length, width, and shortest distance from the peripheral margin of the abscess) of redness, edema, and/or induration and absence of fever (\< 37.7 °C)
次要结局
- Mean Plasma Concentration-time Profile of CG400549(Day 1 predose, Day 1 1hour, Day 1 2hour, Day 1 4hour)
- Status of Subject's Clinical Response(End of Treatment (EOT, 10-14 days after beginning treatment) and Test of Cure (TOC, 21-28 days after beginning treatment))
- Status of Subject's Microbial Eradication Response(End of Treatment (EOT, 10-14 days after beginning treatment) and Test of Cure (TOC, 21-28 days after beginning treatment))
- Overall Summary of Adverse Events(From time of signing the informed consent to Test of Cure (TOC, 21-28 days after after beginning treatment))