NCT00646958已完成2 期
A Phase 2, Multicenter, Randomized, Open-Label, Comparative Study to Evaluate the Safety and Efficacy of RX-1741 Versus Linezolid in the Outpatient Treatment of Adult Patients With Uncomplicated 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
- 150
- 试验地点
- 19
- 主要终点
- Number of Participants With a Clinical Response of Cure
研究概览
简要总结
The purpose of this study is to assess the efficacy, safety and tolerability of RX-1741, an oxazolidinone, versus linezolid, another oxazolidinone, in the treatment of uncomplicated skin and skin structure infections
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with uSSSI
- •Adult (men and women) ≥18 years
- •Females must be post-menopausal for at least 1 year or surgically sterile
- •Sexually active males must use a barrier method of birth control during and for 30 days after the study
- •Acceptable clinical diagnoses of uSSSI include, but are not limited to: Simple abscess, Impetiginous lesions, Folliculitis, Furunculosis, Carbuncles, Cellulitis
- •The infection is accompanied by 2 or more of the following local signs and symptoms: Pain/tenderness, Swelling, Erythema, Localized warmth, Purulent drainage/discharge, Induration, Regional lymph node swelling or tenderness, Extension of redness
- •A sample for microbiologic culture must be obtained from the primary infection site at the screening visit
- •The patient must require and be a suitable candidate for oral antibiotic therapy in the opinion of the Investigator and be able to swallow tablets or capsules intact
- •A written, voluntarily signed informed consent must be obtained from the patient prior to the initiation of any study-related procedures
排除标准
- •Cellulitis (area greater than 10cm2), chronic or recurrent furunculosis, postoperative wound infection, leg ulcer, decubitus ulcer(s), erysipelas, progressive lymphangitis, acute paronychia or a deep tissue abscess such as pilonidal or breast abscess. Also excluded are skin infections resulting from animal bites
- •Patients with a complicated skin and skin structure infection as judged by the Investigator
- •Infections that can be treated by surgical incision alone according to the judgment of the Investigator
- •Treatment with the following anti-infective agents prior to study drug administration: systemic antibiotic within 7 days; azithromycin within 14 days; a long-acting injectable antibiotic within 30 days
- •Any infection which requires the use of a concomitant antimicrobial agent, in addition to study drug
- •Concomitant topical therapy at the infection site for the period within 48 hours prior to study drug administration through TOC
- •A chronic or underlying skin condition at the site of infection or infections involving prosthetic materials
- •A wound secondary to burn injury or acne vulgaris
- •Any infection site that requires: intraoperative surgical debridement; excision of infected area
- •Documented or suspected bacteremia
- •Fungal infection involving the nail bed or scalp at the primary uSSSI site
- •Significant peripheral vascular disease
- •An abscess at an anatomical location where the incidence of anaerobic pathogen involvement is increased
- •Patient receiving a daily dose of > 15 mg of systemic prednisone or equivalent, for > 10 days within the period starting 14 days prior to study drug administration or anticipated through TOC
- •Patient with known human immunodeficiency virus (HIV) infection.
- •Medical history of hypersensitivity or allergic reaction to linezolid according to the judgment of the Investigator
- •Patients receiving serotonergic agents, selective serotonin reuptake inhibitors (SSRIs), or monoamine oxidase inhibitors (MAOIs)
- •Patients who have severe liver disease
- •History of pheochromocytoma, untreated hyperthyroidism, untreated or uncontrolled hypertension, carcinoid syndrome
- •Evidence of uncontrolled, clinically significant (according to the judgment of the Investigator) cardiovascular, pulmonary, metabolic, gastrointestinal, neurological, or endocrine disease; malignancy or psychiatric disorder
- •Current evidence of deep vein thrombosis or superficial thrombophlebitis
- •Experienced a recent clinically significant coagulopathy
- •Evidence of clinically significant immunosuppression
- •Patient who previously enrolled in this study
- •Patient who has previously enrolled in any other clinical trial within 4 weeks of enrollment through TOC. Treatment with an investigational drug within 4 weeks prior to study drug administration
- •Patient residing in a chronic care facility
- •Any underlying condition or disease state that would interfere with the completion of the study procedures and evaluation of the absorption of study drug
研究组 & 干预措施
1
Experimental
Radezolid 450 mg PO QD
干预措施: Radezolid (Drug)
2
Experimental
Radezolid 450 mg PO BID
干预措施: Radezolid (Drug)
3
Active Comparator
Linezolid 600 mg PO BID
干预措施: Linezolid (Drug)
结局指标
主要结局
Number of Participants With a Clinical Response of Cure
时间窗: Test of Cure (TOC), day 10-20
To qualify as a Cure, participants were required to fulfill the following criteria: all systemic signs and symptoms of uSSSI present at screening were improved or resolved; no further antibiotic therapy was necessary for treatment of uSSSI; and there was no worsening or appearance of new signs and symptoms of uSSSI.
次要结局
- Number of Patients With Per-Patient Microbiologic Response of Eradicated(Test of Cure (TOC), day 10-20)
研究者
研究点 (19)
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