NCT00949130已完成2 期
A Multicenter,Investigator-blinded,Randomized, Comparative Study to Evaluate the Efficacy and Safety of Oral NXL103 Versus Oral Linezolid in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Novexel Inc14 个研究点 分布在 2 个国家目标入组 180 人开始时间: 2009年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 14
- 主要终点
- Clinical response at the early follow-up visit (Test of cure)
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of oral NXL103 vs. established treatment of acute bacterial infection in adults.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with acute bacterial skin and skin structure infection (ABSSSI) with at least 3 signs or symptoms
排除标准
- •Uncomplicated acute bacterial skin and skin structure infections
- •ABSSSI suspected or proven to be due to Gram negative and/or anaerobic pathogens
- •Pregnant or lactating women
- •Inadequately controlled diabetes mellitus
- •Inadequately controlled arterial hypertension
- •Moderate-to-severe renal impairment
- •Moderate-to-severe liver disease
- •Conditions associated with immunodeficiency
- •Known hypersensitivity or any contraindication for the use of any of the 2 study drugs
研究组 & 干预措施
NXL103
Experimental
BID for 7-14 days orally
干预措施: NXL103 (Drug)
Linezolid
Active Comparator
BID for 7-14 days orally
干预措施: Linezolid (Drug)
结局指标
主要结局
Clinical response at the early follow-up visit (Test of cure)
时间窗: 7 days post therapy
次要结局
- Clinical outcome at the late follow-up visit(21 days post therapy)
- Clinical outcome at the end of treatment(10-14 days therapy)
- Microbiological outcome at the early follow-up visit (Test of cure)(7 days post-therapy)
- Safety Profiles (safety and tolerability)(throughout the study)
- Population pharmacokinetic profile of the experimental study drug(Day 1-5 while on study drug)
研究者
研究点 (14)
Loading locations...
相似试验
进行中（未招募）
3 期
LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEFPulmonary HypertensionNCT05983250Tenax Therapeutics, Inc.230
已完成
2 期
A Multi-Center Trial to Determine the Safety and Efficacy of LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel SyndromeIrritable Bowel SyndromeNCT01494233Lexicon Pharmaceuticals373
终止
3 期
XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary TumorsBiliary Tract CancerNCT00090025Helsinn Healthcare SA248
已完成
2 期
Study of LX1031 in Subjects With Non-Constipating Irritable Bowel SyndromeIrritable Bowel SyndromeNCT00813098Lexicon Pharmaceuticals155
已完成
2 期
Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal InfectionsComplicated Intra-abdominal InfectionsNCT00752219Pfizer204