NCT00645073已完成4 期
A Phase IV Comparative Study of the Safety and Efficacy of Cefdinir and Levofloxacin for the Treatment of Subjects With Acute Bacterial Sinusitis
适应症
干预措施
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
- 271
- 主要终点
- Clinical cure rate
研究概览
简要总结
To compare the safety and efficacy of a ten-day course of therapy of cefdinir, 600 mg QD, to a ten-day course of therapy of levofloxacin, 500 mg QD, in the treatment of acute bacterial sinusitis.
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 (Participant, Investigator)
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
- •A female must be non-lactating, non-breastfeeding and at no risk for pregnancy.
- •A condition of general good health, based upon the results of a medical history, physical examination, and laboratory profile.
- •Subject must have a diagnosis of acute bacterial sinusitis. The diagnosis must be based on the following:
- •a sinus radiograph or CT scan performed within 48 hours pre-treatment
- •with evidence of maxillary opacification or air/fluid levels
- •Purulent discharge from the nose
- •At least one of the following clinical signs and symptoms of acute bacterial sinusitis
- •Lasting for more than 7 days prior to and no longer than 21 days before Evaluation 1: facial pain over the sinus or facial pressure over the sinus or facial tightness over the sinus or facial swelling or toothache.
- •Subject must be a suitable candidate for oral antimicrobial therapy and is able to swallow capsules intact.
排除标准
- •Subjects who have: chronic sinusitis (signs and symptoms lasting greater than 28 days prior to Evaluation 1)
- •Significant anatomical abnormalities of the sinuses
- •Any other infection or condition which necessitates use of a concomitant systemic antimicrobial.
- •History of any hypersensitivity or allergic reactions to penicillins, cephalosporins (including cefdinir), or quinolones (including levofloxacin).
- •Subject who has taken: a systemic antibiotic within 14 days before study drug administration; a long acting injectable antibiotic (e.g., penicillin G benzathine) within 30 days before study drug administration.
- •Known significant renal or hepatic impairment.
- •Evidence of uncontrolled clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological or endocrine disease, malignancy, or other abnormality (other than the disease being studied).
- •Investigator considers the subject unsuitable for cefdinir or levofloxacin therapy, for any reason.
- •Previous enrollment in this study.
- •Any underlying condition or disease state that would interfere with the completion of the study procedures and evaluations or absorption of study drug.
- •Subject who is currently receiving or who is likely to require any of the following medications during the period between Evaluation 1 (initial presentation to office/clinic) and Evaluation 3 (or within 48 hours after the last dose of study drug): Concomitant theophylline or any theophylline analog, unless plasma levels of these drugs can be adequately monitored during the study; Warfarin and probenecid.
- •Immunocompromised subjects.
- •Subject who requires parenteral antibiotic therapy for this infection or who has any other infection or condition, that necessitates use of a concomitant systemic antibiotic.
- •Subjects receiving antacids containing magnesium, or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc within 2 hours before or after dosing with study drug.
- •Subjects with a known or suspected central nervous system disorder that may predispose the subject to seizures or lower the seizure threshold.
研究组 & 干预措施
A
Active Comparator
干预措施: cefdinir (Omnicef) (Drug)
B
Active Comparator
干预措施: levofloxacin (Drug)
结局指标
主要结局
Clinical cure rate
时间窗: 26 days
次要结局
- Radiographic response(26 days)
- Changes from baseline in clinical signs and symptoms(26 days)
研究者
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