NCT00234949已完成4 期
A Comparative Study of the Safety, Tolerability, and Efficacy of Cefdinir and Cephalexin for the Treatment of Subjects With Mild to Moderate Uncomplicated Skin and Skin Structure Infections
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 380
- 主要终点
- Clinical cure rate
研究概览
简要总结
The purpose of this study is to compare the efficacy and tolerability of cefdinir to that of cephalexin in patients with mild to moderate uncomplicated skin/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
- Single
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory male or female subjects > 13 years old.
- •A female subject must be non-lactating and at no risk for pregnancy.
- •Diagnosis of USSSI with 2 or more of the following local signs and symptoms:
- •Pain/tenderness
- •Localized warmth
- •Purulent drainage/discharge
- •Induration
- •Regional lymph node swelling or tenderness
- •Extension of redness
- •Acceptable USSSI include, but are not limited to:
- •Cellulitis
- •Erysipelas
- •Simple abscess
- •Wound infection
- •Furunculosis
- •Folliculitis
- •A sample for microbiologic culture must be obtained from the primary infection site within 48 hours prior to study drug administration.
- •Exclusion Criteria
- •Medical history of hypersensitivity or allergic reaction to penicillin and/or cephalosporin (including cefdinir and cephalexin) antibiotics according to the judgment of the Investigator.
- •Subject with a complicated skin and skin structure infection as judged by the investigator.
- •A chronic or underlying skin condition at the site of infection (e.g., a secondary infected atopic dermatitis or eczema) or infections involving prosthetic materials (e.g., catheter tunnel infections, orthopedic hardware).
- •A wound secondary to burn injury or acne vulgaris.
- •Any infection site that requires:
- •intraoperative surgical debridement;
- •excision of infected lesions or body parts.
- •Infections that can be treated by surgical incision alone according to the judgment of the Investigator.
- •Any other infection that necessitates the use of additional concomitant oral or parenteral antibiotic therapy.
- •Known significant renal or hepatic impairment indicated by:
- •Serum Creatinine > 2.0 mg/dL (176.8 mol/L)
- •SGOT (AST) > 3x the upper limit of the reference range
- •SGPT (ALT) > 3x the upper limit of the reference range
- •Alkaline Phosphatase > 2x the upper limit of the reference range
- •Total Bilirubin > 2x the upper limit of the reference range
- •Underlying condition and/or disease that, according to the judgment of the Investigator, would be likely to interfere with completion of the course of study drug therapy or follow-up.
- •The Investigator considers the subject an unsuitable candidate for cefdinir or cephalexin administration
排除标准
- 未提供
结局指标
主要结局
Clinical cure rate
次要结局
- Adverse event rates
- Bacteriologic cure rates
- Patient reported outcomes
研究者
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