Randomized, Dose Ranging, Active Controlled Efficacy and Safety Evaluation of PMX-30063 As Initial Treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Caused by Staphylococcus Aureus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 215
- 试验地点
- 2
- 主要终点
- The Primary objective of this study is to assess the efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI).
研究概览
简要总结
The study investigates the safety and efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI).
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 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of ABSSSI in which S. aureus is clinically suspected to be the likely pathogen
- •Clinical manifestation of subjects' ABSSSI must include the presence of purulent material suitable for microbiologic culture, Gram stain examination and PCR assay.
- •The ABSSSI must be 75 cm2 or greater in size in order for the subject to be eligible for this study. This includes the primary and surrounding erythema, swelling or induration.
- •Super-infected eczema or other chronic medical conditions (e.g., atopic dermatitis, hidradentitis suppurativa) characterized by prominent signs of inflammation for an extended period even after successful bacterial eradication. (Subjects with an ABSSSI that involves an anatomic location in which there is no evidence of a chronic skin condition are eligible for enrollment.)
排除标准
- •Female patients who are pregnant, lactating (breast milk feeding), or planning a pregnancy during the course of the study.
- •History of peripheral neuropathy of any form or etiology
- •Anticipated need for prolonged antibiotic therapy (i.e., >8 days)
- •ABSSSI known or suspected to be caused exclusively by Gram negative pathogens or anaerobes (both Gram positive or Gram negative)
- •Diabetic foot infection: defined as a subacute or chronic infection (> 4 weeks) below the ankle in a patient with diabetic neuropathy
- •Infected burns
- •Known infection with human immunodeficiency virus (HIV) and a CD4 count < 200/mm3
- •Active hepatitis B or hepatitis C receiving treatment with interferon or other immunosuppressive therapy
研究组 & 干预措施
PMX-30063
3 arms of PMX-300063
干预措施: PMX-30063-investigational drug (Drug)
Daptomycin.
Daptomycin will be administered according to the approved product monograph information for ABSSSI.
干预措施: Daptomycin (Drug)
结局指标
主要结局
The Primary objective of this study is to assess the efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI).
时间窗: Eradication at end of treatment (day 7/8)
The Primary objective of this study is to assess the efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI). The primary measure of efficacy will be bacteriologic eradication at end of treatment of S. aureus (either Methicillin-susceptible (MSSA) or Methicillin-resistant (MRSA)) in subjects with ABSSSI and having S. aureus isolated from an appropriate infection site prior to randomization. The secondary objectives are clinical responses, safety and pharokinetics of PMX-300063.
次要结局
未报告次要终点