Prospective, Randomized, Observational Cohort Study of Antibiotic Resistance After Repeated Application of Topical Antibiotics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Establish baseline susceptibility and resistance patterns of normal conjunctival and nasopharyngeal flora of patients with choroidal neovascularization.
研究概览
简要总结
Repeated exposure to topical antibiotics may alter the normal bacteria on the eye and in the nose and increase rates of resistance. This study will determine whether repeated short-term exposure to topical antibiotic drops which are commonly prescribed after eye injections to reduce the chance of infection increase rates of resistant bacteria which are normally found on the eye and in the nose.
We hypothesis that certain commercially available antibiotics may increase rates of bacteria resistance more so than others.
详细描述
Introduction
The treatment of neovascular age-related macular degeneration (AMD) with anti-vascular endothelial growth therapy (ranibizumab and bevacizumab, Genentech, South San Francisco, CA) requires repetitive and often long-term intraocular injections and has raised concern about increasing rates of endophthalmitis. Endophthalmitis remains one of the most feared complications in ophthalmology and despite early detection and intervention can result in substantial morbidity. Recent multicenter clinical trials of anti-vascular endothelial growth therapy have reported endophthalmitis rates of 1.0% to 1.9% per patient treated (during a 6 month to 2 year period of follow-up). Consequently, topical antibiotics are routinely prescribed after intraocular injections, although no published study to date has proven their efficacy in preventing post-injection endophthalmitis. 1,2
Of increasing concern, however, are reports of growing resistance of normal ocular flora to commonly employed antibiotic classes including macrolides, aminoglycosides, and 3rd generation fluoroquinolones.3-5 The recent availability of 4th generation fluoroquinolones: gatifloxacin 0.3% (Zymar, Allergan Pharmaceuticals, Irvine, Calif) and moxifloxacin 0.5% (Vigamox, Alcon Fort Worth, TX) has notably enhanced our armamentarium and are widely used due to their greater potency. Not surprisingly however, recent reports have begun to surface documenting emerging resistance to these 4th generation fluoroquinolones as well.6,7
The practice of short-term and repeated exposure of ocular flora to antibiotics, as is the case after intraocular injections for AMD, may facilitate antibiotic resistance. However, no study to date has evaluated resistance patterns of ocular or nasopharyngeal flora in response to repeated applications of topical antibiotics over time.
Therefore, this study will attempt to monitor long-term resistance patterns of conjunctival and nasopharyngeal flora in patients with AMD who are repeatedly exposed to different commercially available antibiotics after intraocular injections.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •age greater than 18 with choroidal neovascularization with planned treatment with intravitreal injections
排除标准
- •Use of topical antibiotics for any reason within 3 months, current use of systemic or topical antibiotics, known allergies to gatifloxacin, moxifloxacin, ofloxacin, and azithromycin
结局指标
主要结局
Establish baseline susceptibility and resistance patterns of normal conjunctival and nasopharyngeal flora of patients with choroidal neovascularization.
时间窗: 2 years
Monitor changes in normal conjunctival and nasopharyngeal flora after repeated exposure to topical antibiotics over a 2 year period.
时间窗: 2
次要结局
未报告次要终点
研究者
Stephen J. Kim, MD
Associate Professor of Ophthalmology
Vanderbilt University