Antibiotic Resistance In Eye Surgeries (ARIES)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Antimicrobial Resistance (AMR) of Conjunctiva at 1 Week
研究概览
简要总结
In this study, the investigators seek to determine the effect of antibiotic use post-surgery on antimicrobial resistance. The investigators will be studying adults (aged 18 or older) who will undergo eye surgery at University of California, San Francisco (UCSF). We seek to gain a better understanding of how antibiotic use during the perioperative period influences local and systemic antibiotic resistance at the individual level.
详细描述
Antibiotic use has saved millions of lives globally. However, this comes at the cost of selecting for antibiotic-resistant organisms at the individual and the community level. It is estimated that every year, approximately 700,000 deaths are associated with drug resistance globally. This places a significant burden on the public health system and the judicious use of antibiotics is more important than ever before.
The proposed masked, randomized controlled trial evaluates the effects of topical antibiotic use on the selection of antibiotic resistance determinants at the local and systemic levels. The results will provide guidance for antibiotic usage in ophthalmology and may have the potential to inform public health policies.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years of age
- •Undergoing cataract surgeries that would benefit from intracameral antibiotics
- •Able to provide swabs
- •Able to provide consent
- •Surgery of the second eye occurs at least 8 weeks after surgery of the first eye
排除标准
- •Same-day bilateral cataract surgeries
- •On immunosuppression medication such as Prednisone, Methotrexate, Cellcept, or anti-TNF inhibitors within past 3 months
- •On systemic antibiotic within past 3 months
- •On topical antibiotics within past 8 weeks
- •Allergies to fluoroquinolone
- •Patients needing glaucoma drainage device or trabeculectomy
- •Inability to consent
研究组 & 干预措施
Intraoperative antibiotics (Abx) only; no postoperative topical antibiotics
intraoperative/ intracameral antibiotic (moxifloxacin) only; no postoperative topical antibiotic drops
干预措施: Moxifloxacin (Topical) (Drug)
Intraoperative antibiotics (Abx); Postoperative topical antibiotics four times a day for 1 week
intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops four times a day for 1 week
干预措施: Moxifloxacin (Topical) (Drug)
Intraoperative antibiotics (Abx); Postoperative topical antibiotics once a day for 1 week
intraoperative/ intracameral antibiotic (moxifloxacin); postoperative topical antibiotic drops once a day for 1 week
干预措施: Moxifloxacin (Topical) (Drug)
结局指标
主要结局
Antimicrobial Resistance (AMR) of Conjunctiva at 1 Week
时间窗: 1 Week
Normalized read counts (reads per million reads or rM) for fluoroquinolone resistance determinants from DNA deep sequencing for the conjunctival swabs at 1 week, which represent the abundance of resistance in the sample.
次要结局
- Antimicrobial Resistance (AMR) of Nasopharynx at 1 Week(1 week)
- Shannon's Index(1 week)
- Simpson's Index(1 week)