A Phase 2, Randomized, Double-blind, Multi-center Study to Evaluate the Safety and Efficacy of CEM-102 Compared to Linezolid in the Treatment of Acute Bacterial Skin Structure Infections
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Arrevus Inc.
- 入组人数
- 198
- 主要终点
- Clinical Success at Test of Cure (TOC) for the intent-to-treat (ITT) population
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of CEM-102 compared to Linezolid in the treatment of acute bacterial skin structure infections (ABSSIs).
详细描述
ABSSIs are common and affect all age groups. In recent years, ABSSIs caused by multi-drug resistant pathogens, especially methicillin-resistant Staphylococcus aureus (MRSA) have become more common. There is an urgent need for additional antibacterial drugs with modes of action different from those currently available. CEM-102 is one such agent with excellent activity against S. aureus, including MRSA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 acute bacterial skin-structure infection (ABSSI) of no more than 7 days duration which was suspected or proven to be caused, at least in part, by a gram-positive pathogen.
- •Eligible infections included cellulitis measuring at least 10 cm length and width or 100 cm squared, with or without a focal abscess, and surgical or traumatic wound infections
- •Infection which in the opinion of the investigator will require 10-14 days of antibacterial therapy.
- •Have at least 3 of the following local and/or systemic symptoms and/or signs of infection: purulent or seropurulent drainage/discharge, erythema, fluctuance, heat/localized warmth, pain/tenderness to palpation, swelling/induration, regional lymph node swelling or tenderness, temperature >=100.4 degree F, increased white blood cell count, or bandemia.
- •Must not have received treatment with another systemic antibiotic for the current ABSSI.
排除标准
- •Superficial skin structure infections such as folliculitis, carbuncles, furunculosis, cutaneous abscesses, and simple cellulitis.
- •Infections involving burns, human or animal bites, or chronic diabetic foot ulcers.
- •Suspected polymicrobial infection involving Pseudomonas aeruginosa
- •Anticipated need for >14 days of antibiotic therapy.
- •Infections complicated by the presence of prosthetic materials that will not be removed, such as permanent cardiac pacemaker battery packs, mesh, or joint replacement prosthesis.
- •Known significant renal, hepatic, or hematologic impairment.
- •Received prior potentially effective antimicrobial therapy for the acute bacterial skin and skin structure infection, unless they were failing therapy after 48 hours or had a gram-positive pathogen non-susceptible to prior therapy identified as a causative pathogen.
研究组 & 干预措施
Linezolid
600 mg BID
干预措施: Linezolid (Drug)
CEM-102 Regimen A
干预措施: CEM-102 (Drug)
CEM-102 Regimen B
干预措施: CEM-102 (Drug)
结局指标
主要结局
Clinical Success at Test of Cure (TOC) for the intent-to-treat (ITT) population
时间窗: 7 to 14 days after the last dose of study drug
Meets the following definition for clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required
Clinical Success at Test of Cure (TOC) for the clinically evaluable (CE) population
时间窗: 7 to 14 days after the last dose of study drug
Meets the following definition for clinical success: continued complete resolution of the signs and symptoms of the ABSSI and no additional systemic antibacterial therapy is required
次要结局
- Clinical Success at end of treatment (EOT) for the intent-to-treat (ITT) population(10-14 days of study drug)
- Clinical Success at the test of cure (TOC) in the microbiological intent-to-treat (MITT) and population(7 to 14 days after the last dose of study drug)
- Clinical Success at the end of treatment (EOT) for the Clinically evaluable (CE) population(10-14 days of study drug)
- Clinical success at the end of treatment (EOT) for the microbiological intent-to-treat (MITT) population(10-14 days of study drug)
- Clinical Success at end of treatment (EOT) for the microbiologically evaluable (ME) population(10-14 days of study drug)
- Clinical Success at test of cure (TOC) for the microbiologically evaluable (ME) population(7-14 days after the last dose of study drug)
- Clinical success at the test of cure (TOC) by baseline pathogen for the microbiological intent-to-treat (MITT) population(7-14 days after the last dose of study drug)
- Clinical success at test of cure (TOC) by baseline pathogen for the microbiologically evaluable (ME) population(7 to 14 days after the last dose of study drug)
- By-pathogen microbiological success at test of cure (TOC) for the microbiological intent-to-treat (MITT) population(7-14 days after the last dose of study drug)
- By-pathogen microbiological success at test of cure (TOC) for the microbiologically evaluable (ME) population(7-14 days after the last dose of study drug)
- By-patient microbiological success at test of cure (TOC) for the microbiological intent-to-treat (MITT) population(7-14 days after the last dose of study drug)
- By-patient microbiological success at test of cure (TOC) for the microbiologically evaluable (ME) population(7-14 days after the last dose of study drug)