NCT00245440终止4 期
Influence of Oral Telithromycin vs. Azithromycin on the Endogenous Microflora in Adults With Acute Sinusitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Bacterial resistance or selection
研究概览
简要总结
The purpose of this study is to measure the speed of microbial eradication due to azithromycin or telithromycin in acute maxillary sinusitis (AMS).
详细描述
The objectives of this study are:
- To assess the impact of therapy with telithromycin vs. azithromycin on the oral microflora in patients with acute maxillary sinusitis at day 42 and to compare the duration of colonization with resistant oropharyngeal flora in patients treated with azithromycin vs. telithromycin.
- To also compare the two treatment groups for rate of reinfection within 6 weeks and the susceptibility pattern of the organisms appearing during the reinfection and differences in development of resistance and the associated changes in symptom responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, either males or non-pregnant females, aged 18 to 75 years of age with clinical findings of acute maxillary sinusitis (AMS), who are amenable to serial sampling of the nasopharynx and oropharynx.
- •Patients are required to have specimens of nasal and nasopharyngeal drainage collected for microbiological documentation within 24 hours prior to enrollment. All patients must produce sinus fluid drainage.
- •All patients will produce nasal or nasopharyngeal discharge sufficient for baseline culture.
- •Female patients of child bearing potential must agree to use an accepted method of contraception (i.e., oral or implanted contraceptive with a barrier method, spermicide and barrier methods, or intrauterine device [IUD]). The patient must agree to continue with the same method throughout the study.
排除标准
- •Patients with a history of recurrent sinusitis defined as more than three episodes of sinusitis which required antibiotic therapy in the preceding 12 months
- •Patients with a history of chronic sinusitis defined as symptoms lasting greater than 28 days
- •Patients with nosocomial acquired sinusitis (e.g., hospitalization or non-ambulatory institutional confinement including nursing homes within 2 weeks)
- •Patients with a need for immediate surgery for maxillary sinusitis or previous sinus surgery within the past 6 months or sinus lavage within the past 7 days
- •Patients who are long-term (> 4 weeks) users of nasal decongestants (e.g. oxymetazoline 0.05%)
- •Patients with a known or suspected hypersensitivity to, or a known or suspected serious adverse reaction to, any macrolide antibiotic
- •Impaired hepatic or renal function (creatinine clearance [CCL] <20 ml/min)
- •Severe respiratory tract infections requiring hospitalization and parenteral antibiotic therapy.
- •Requirement for a concomitant antimicrobial agent other than topical, antiviral or antifungal agents.
- •Treatment with any macrolide, azalide, or ketolide antimicrobial within the 30 days prior to entry into the study.
研究组 & 干预措施
1
Active Comparator
Subjects assigned Azithromycin
干预措施: Azithromycin (Drug)
2
Active Comparator
Subjects assigned Telithromycin
干预措施: Telithromycin (Drug)
结局指标
主要结局
Bacterial resistance or selection
时间窗: 42 days
次要结局
- Bacteriologic outcome(42 days)
研究者
研究点 (1)
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