NCT00270517Unknown2 期
A Randomized, Double-Blinded, Parallel Group, Multicenter Study of EDP-420 Versus Telithromycin for the Treatment of Community Acquired Pneumonia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Clinical Cure 7-14 days after end of therapy
研究概览
简要总结
This study will compare the efficacy, safety and tolerability of EDP-420 versus another oral antibiotic in the treatment of community acquired pneumonia
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
- Double
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
- •Recent respiratory illness with signs and symptoms and chest X-ray consistent with the diagnosis of community-acquired pneumonia.
- •Suitable candidate for oral antibiotic therapy and able to swallow large capsules intact
- •If female, must be non-lactating and at no risk for pregnancy
排除标准
- •Other infections
- •Other pulmonary diseases requirement multiple antibacterial medications or long duration of therapy
- •History of hypersensitivity, allergic or adverse reactions to macrolide, ketolide, azalide or streptogramins
- •Evidence of uncontrolled clinically significant disease, malignancy, or other abnormality
- •Requirement of parenteral antimicrobial therapy for treatment of pneumonia
- •Currently receiving or likely to receive any known inhibitors or inducers of cytochrome P450 mediated drug metabolism
- •Immunocompromised subjects
结局指标
主要结局
Clinical Cure 7-14 days after end of therapy
次要结局
- Bacteriological response
- Radiographic response
- Change in signs and symptoms
- Safety
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Clinical Study to Evaluate the Efficacy and Safety of VR506 Using a New Inhaler for the Treatment of AsthmaAsthmaNCT01720069Vectura Limited197
已完成
1 期
Comparing of the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Xgeva® in Healthy AdultsHealthy PeopleNCT03651947Qilu Pharmaceutical Co., Ltd.168
Unknown
1 期
Comparing of the Pharmacokinetic, Safety and Pharmacodynamic of QL1206 and Prolia® in Healthy AdultsHealthy PeopleNCT04213105Qilu Pharmaceutical Co., Ltd.144
已完成
2 期
Study Evaluating ERB-041 With Methotrexate in Rheumatoid ArthritisRheumatoid ArthritisNCT00141830Wyeth is now a wholly owned subsidiary of Pfizer159
已完成
3 期
Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement SurgeryThromboembolismArthroplasty, Replacement, HipNCT00168818Boehringer Ingelheim3,494