A Phase III, Multi-centre, Randomized Study to Compare the Efficacy and Safety of Levonadifloxacin (IV and Oral) With Linezolid (IV and Oral) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Wockhardt
- 入组人数
- 501
- 试验地点
- 32
- 主要终点
- To establish the non-inferiority of IV levonadifloxacin with IV linezolid in ABSSSI measuring the Overall Clinical Response at Test of Cure (TOC) visit in modified Intentto-treat (mITT) population in IV treatment subgroups
研究概览
简要总结
This is a phase III, multi-center, randomized, active-comparator, study in subjects with ABSSSI. The study has two subgroups for assessment of efficacy and safety - oral subgroup 1 and IV subgroup 2. Each subgroup will comprise of two treatment arms.
详细描述
Subjects willing to participate in the study and fulfilling all eligibility criteria will receive either oral therapy (subgroup 1) or IV therapy (subgroup 2). The investigator can initiate treatment with either oral or IV therapy based on clinical judgement i.e subjects who require IV therapy (like subjects with severe ABSSSI or where oral administration is not feasible).
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be willing to participate in the study and provide a written informed consent
- •Subjects with ABSSSI characterized by any of the following infection types:
- •Cellulitis/erysipelas: diffuse skin infection characterized by spreading areas of redness, edema, and/or induration
- •Wound infection: An infection characterized by purulent drainage from a wound with surrounding redness, edema, and/or induration
- •Major cutaneous abscess: An infection characterized by a collection of pus within the dermis or deeper that is accompanied by redness, edema, and/or induration
- •Subjects with lesion size area of at-least 75 cm
- •Lesion size will be measured by the area of redness, edema, or induration
- •Subjects with suspected and/or documented evidence of Gram-positive infection
排除标准
- •ABSSSI meeting any of the following criteria:
- •Severely impaired arterial blood supply (such that the likelihood of amputation of the infected anatomical site is likely)
- •ABSSSI expected to require more than 10 days of antimicrobial therapy as per the discretion of the Investigator
- •Subject with suspected or confirmed osteomyelitis or septic arthritis or gangrene
- •ABSSSI requiring surgical intervention (except surgical incision and drainage for abscess)
- •Subjects who have received prior antibiotic therapy within past 24 hours for the treatment of current episode of ABSSSI. Following are the exceptions to this criteria:
- •Subjects who received a single dose of a short-acting antibacterial drug within 24 hours of enrolment
- •Subjects with evidence of clinical progression of ABSSSI while on antibacterial drug therapy after at-least 48 hours
- •Subjects who received an antibacterial drug for surgical prophylaxis and subsequently develop ABSSSI
- •Subjects with current history or diagnosis of HIV, positive test result for hepatitis B surface antigen (HBsAg) or Hepatitis C virus (HCV)
- •Subjects with any clinically significant abnormalities in pulmonary, gastrointestinal, endocrine, hepatic or renal systems
研究组 & 干预措施
linezolid
oral linezolid (600 mg BID) or IV linezolid (600 mg BID)
干预措施: Intravenous Levonadifloxacin/Linezolid Infusion (Drug)
levonadifloxacin
oral levonadifloxacin (1000 mg BID) or IV levonadifloxacin (800 mg BID)
干预措施: Oral Levonadifloxacin/Linezolid Tablet (Drug)
levonadifloxacin
oral levonadifloxacin (1000 mg BID) or IV levonadifloxacin (800 mg BID)
干预措施: Intravenous Levonadifloxacin/Linezolid Infusion (Drug)
linezolid
oral linezolid (600 mg BID) or IV linezolid (600 mg BID)
干预措施: Oral Levonadifloxacin/Linezolid Tablet (Drug)
结局指标
主要结局
To establish the non-inferiority of IV levonadifloxacin with IV linezolid in ABSSSI measuring the Overall Clinical Response at Test of Cure (TOC) visit in modified Intentto-treat (mITT) population in IV treatment subgroups
时间窗: 0-14 days
The non-inferiority of oral levonadifloxacin with oral linezolid in ABSSSI by measuring the Overall Clinical Response at Test of Cure (TOC) visit in modified Intentto-treat (mITT) population in oral treatment subgroups
时间窗: 0-14 days
次要结局
- The safety of oral and IV levonadifloxacin based on adverse events reported, vital signs and physical examination findings, clinical laboratory evaluation, and ECG collected during the study.(0-14 days)