Oral Versus Topical Antibiotic Therapy for Treatment of Chronic Rhinosinusitis Exacerbations
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change in Rhinosinusitis Disability Index (RSDI) Score
研究概览
简要总结
The purpose of this study is to treat patients with a diagnosis of chronic rhinosinusitis (CRS) and a history of bilateral endoscopic sinus surgery during times of worsening symptoms and signs of acute infection on nasal endoscopy with one of two treatments: (1) oral antibiotics and twice daily intranasal saline irrigations or (2) oral placebo and twice daily intranasal antibiotic irrigations. The two treatments will be compared to see if there is any difference in patient outcomes. This will help guide treatment strategies for patients with CRS in the future.
详细描述
See brief summary.
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, Outcomes Assessor)
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
- •Adults (age ≥ 18).
- •Diagnosis of CRS.
- •Worsening sinonasal symptoms.
- •Previous bilateral endoscopic sinus surgery (ESS) (including maxillary antrostomy and anterior ethmoidectomy).
- •English speaking.
- •Open sinuses (open middle meatus bilaterally; determined on endoscopy).
- •Positive sinonasal culture (1+ or greater) with sensitivity to one of the pre-chosen antibiotic regimens.
排除标准
- •Patients < 18 years of age.
- •Treatment with systemic or topical antibiotics within the last 1 month.
- •Pregnant women.
- •Non-English speaking persons.
- •Systemically ill at initial visit necessitating treatment prior to culture data.
- •Allergies to chosen susceptible antibiotics.
- •Sinonasal culture with less than 1+ growth.
- •Multiple organisms grown on culture that are not sensitive to a single antibiotic.
- •Patients with ciliary function disorders (cystic fibrosis, Kartagener's syndrome, ciliary dyskinesia).
- •Patients with immunodeficiencies.
研究组 & 干预措施
oral placebo with nebulized intranasal levofloxacin
Placebo oral tablet by mouth daily for 14 consecutive days along with nebulized levofloxacin 125 mg twice daily for 14 consecutive days
干预措施: oral levofloxacin (Drug)
oral placebo with nebulized intranasal levofloxacin
Placebo oral tablet by mouth daily for 14 consecutive days along with nebulized levofloxacin 125 mg twice daily for 14 consecutive days
干预措施: nebulized levofloxacin (Drug)
oral antibiotics with nebulized intranasal placebo
Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days.
干预措施: oral levofloxacin (Drug)
oral antibiotics with nebulized intranasal placebo
Levofloxacin 500 mg by mouth once daily for 14 consecutive days, along with intranasal placebo solution twice daily for 14 consecutive days.
干预措施: nebulized levofloxacin (Drug)
结局指标
主要结局
Change in Rhinosinusitis Disability Index (RSDI) Score
时间窗: Baseline and 14 days after treatment
The Rhinosinusitis Disability Index is a 30-item questionnaire completed by the patient or subject. Each item has a value of zero to four, a higher score indicates a self-perception of worse symptoms. The minimum score is zero and the maximum score is 120. The difference score here is the post-treatment score minus the pre-treatment score, with lower meaning more improvement
次要结局
- Change in Sino-nasal Outcome Test (SNOT-22) Score(Baseline and 14 days after treatment)
- Change in Bilateral Endoscopy Findings Using POSE Score(Baseline and 14 days after treatment)
- Number of Participants With Post-treatment Culture Negativity(14 days after treatment)
- Mean Change in the Total Bacterial Community(Baseline and 14 days after treatment)
研究者
Li-Xing Man
M.D.
University of Rochester