NCT01128530已完成2 期
A Randomized, Controlled, Double-Blind, Double Dummy, Multicenter Phase 2 Study of the Safety/Tolerability and Efficacy of JNJ-32729463 Compared With Linezolid (Zyvox) for the Treatment of Complicated Skin and Skin Structure Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Cessation of spread or reduction in the size of the primary infection site lesion
研究概览
简要总结
The purpose of this study is to determine the clinical efficacy, safety, and tolerability of a 250 mg BID oral dose of JNJ-32729463 compared with linezolid in subjects with complicated skin and skin structure infections (cSSSIs).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of a complicated skin and skin structure infection (cSSSI) including wound infection, deep cellulitis or severe abscess
- •Women of childbearing potential must agree to use an acceptable form of contraception
- •Infection site offers ability to obtain a microbiological specimen
- •Received only 1 dose of any potentially effective systemic antibiotic within 24 hours of beginning study treatment
排除标准
- •History of hypersensitivity or allergic reaction to quinolones or to linezolid
- •Female and pregnant or breastfeeding or may be pregnant
- •Chronic or underlying skin condition surrounding the area of infection that may complicate the assessment of response (e.g. atopic dermatitis, eczema, or psoriasis)
- •Subject has infections with a high cure rate after surgical incision alone after aggressive local skin care
- •Subject has infection(s) suspected to be caused by Gram-negative rods, anaerobic bacteria or unusual pathogens
- •Subject has an infection that is expected to require other antifungal, antimycobacterial, or antibacterial agents in addition to study medication
- •Other protocol-specific eligibility criteria may apply
研究组 & 干预措施
JNJ-32729463
Experimental
JNJ-32729463 250 mg tablet and matching linezolid placebo twice daily
干预措施: JNJ-32729463 (Drug)
JNJ-32729463
Experimental
JNJ-32729463 250 mg tablet and matching linezolid placebo twice daily
干预措施: linezolid placebo (Drug)
linezolid
Active Comparator
linezolid 600 mg tablet and matching JNJ-32729463 placebo twice daily
干预措施: linezolid (Drug)
linezolid
Active Comparator
linezolid 600 mg tablet and matching JNJ-32729463 placebo twice daily
干预措施: JNJ-32729463 placebo (Drug)
结局指标
主要结局
Cessation of spread or reduction in the size of the primary infection site lesion
时间窗: 48-72 hours
Defervescence
时间窗: 48 - 72 hours
次要结局
- Severity of signs and symptoms of the primary infection site lesion(up to day 84-98 (late follow-up visit))
- Clinical response rate - overall and for MRSA(Day 10 (TOC visit), Day 15-21 (SFU/EOT visit))
- Microbiological response rate - overall and for MRSA(Day 15-21 (SFU/EOT visit))
- Change in susceptibility testing of S. aureus(Day 15-21 (SFU/EOT visit))
- Rate of recurrence and new infection in subjects with MRSA(Day 35-49 and Day 84-98)
- Defervescence(Day 4 (Visit 3))
- Cessation of spread or reduction in the size of the primary infection site lesion(Day 4 (Visit 3))
研究者
研究点 (1)
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