A Randomized, Double-blind, Multi-center Study to Evaluate the Safety and Efficacy of Oral Sodium Fusidate (CEM-102) Compared to Oral Linezolid in the Treatment of Acute Bacterial Skin and Skin Structure Infections
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Arrevus Inc.
- 入组人数
- 716
- 主要终点
- Proportion of subjects with a response for Early Clinical Response
研究概览
简要总结
Phase 3, randomized, double-blind, multi-center efficacy and safety study to evaluate an oral CEM-102 loading dose regimen compared to oral linezolid in the treatment of subjects with ABSSSI
详细描述
The primary objective is to demonstrate the non-inferiority of oral CEM-102 (loading dose regimen of 1500 mg every 12 hours for 2 doses, followed by 600 mg every 12 hours thereafter) compared to oral linezolid (600 mg every 12 hours), each administered for 10 days, for Early Clinical Response (ECR) in the intent to treat (ITT) analysis set in subjects with acute bacterial skin and skin structure infections (ABSSSI). Subjects with an ABSSSI caused by suspected or documented Gram-positive pathogen(s) at baseline will be randomized 1:1 to study treatment
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents between 12 to 18 years old must weigh >60 kg
- •Patients diagnosed with ABSSSI with at least one systemic sign of infection
- •Diagnosed with cellulitis, major cutaneous abscess, or wound infections (traumatic or surgical)
- •Surface redness, edema or induration must be of a minimum surface area of 75 cm2, or extending ≥5 cm from the peripheral margin of the abscess
- •Suspected or documented ABSSSI caused by a Gram-positive pathogen
排除标准
- •Involving a chronic diabetic foot infection (diabetic foot ulcer)
- •Involving burns
- •Involving an anatomical location (e.g. perirectal area) where the incidence of Gram-negative and/or anaerobic pathogen involvement is likely
- •Documented bacteremia associated with the current ABSSSI
- •Known severe renal impairment, as indicated by estimated CrCl <30 mL/min (by Cockcroft-Gault calculation)
- •Evidence of significant liver disease: ALT >3x ULN, or direct bilirubin >ULN; known cirrhosis with decompensation (i.e. Child-Pugh Class B or C disease)
研究组 & 干预措施
CEM-102 (Sodium fusidate)
1500 mg by mouth every 12 hours for 2 doses, then 600 mg by mouth every 12 hours thereafter, until end of therapy (10 days total)
干预措施: sodium fusidate (Drug)
Linezolid
600 mg by mouth every 12 hours for 10 days
干预措施: linezolid (Drug)
结局指标
主要结局
Proportion of subjects with a response for Early Clinical Response
时间窗: 48 to 72 hours after starting treatment
Proportion of subjects with a response for Early Clinical Response (ECR), defined as alive and achieved ≥ 20% reduction from baseline in the lesion size at 48-72 hours after start of study drug, without receipt of additional non-study antibiotic therapy.
次要结局
- Proportion of subjects with clinical success at Post-treatment Evaluation(7 to 14 days after end of treatment)
- Incidence of adverse events [Safety and tolerability], Clinical Laboratory Evaluations(Up to 24 months)