Topical Antibiotics in Chronic Rhinosinusitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Subjects Who Developed Antibiotic Resistance Organisms
研究概览
简要总结
Researchers are trying to find out if patients develop antibiotic resistant organisms after the use of topical antibiotics in the treatment of chronic rhinosinusitis.
详细描述
There is a certain group of patients that has chronic rhinosinusitis that has continued even with treatment including saline and steroid nasal irrigations as well as oral steroids and antibiotics and surgery.
In these patients, the use of topical antibiotic nasal rinses may be of benefit to their disease. The use of topical antibiotic nasal rinses is commonly used as standard of care already throughout the country for refractory chronic rhinosinusitis including here at the Mayo Clinic. Our pharmacy has compounded this medication for this specific purpose. As such, this study is not aimed at a 'novel medication', but rather to investigate the efficacy of a medication already in common use but without great evidence.
The investigators are doing this research study to find out if patients develop antibiotic resistant organisms after the use of topical antibiotics in the treatment of chronic rhinosinusitis.
In addition, this study will look at the effects of topical antibiotics on patient symptoms as measured by a patient survey called the Sino-Nasal Outcomes Test (SNOT-22) and in-office an exam of the inside of their nose, including with a scope (a camera on the end of a long tube).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, between 18-80 years old, diagnosed with chronic rhinosinusitis who have undergone previous functional endoscopic sinus surgery including at minimum maxillary antrostomy and anterior ethmoidectomy
- •Active mucopurulence on endoscopic examination with corresponding culture demonstrating pathogenic bacterial growth
- •Completion of written informed consent
- •No prior enrollment into this study
- •Refractory to maximal medical therapy
排除标准
- •Patient has not had prior endoscopic sinus surgery consisting of at minimum maxillary antrostomy and anterior ethmoidectomy
- •Patient is currently being treated with oral antibiotics
- •Patient has been treated with oral or topical antibiotics within the past 14 days
- •Participation in an investigational drug study simultaneously with participation in this study
- •Concurrent use of oral steroids
- •Allergy to Tobramycin, Mupirocin, Gentamicin and Levofloxacin
- •Known to currently be pregnant
研究组 & 干预措施
Mupirocin Topical Antibiotic Nasal Saline Rinse
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Mupirocin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
干预措施: Mupirocin (Drug)
Tobramycin Topical Antibiotic Nasal Saline Rinse
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Tobramycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
干预措施: Tobramycin (Drug)
Levofloxacin Topical Antibiotic Nasal Saline Rinse
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Levofloxacin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
干预措施: Levofloxacin (Drug)
Vancomycin Topical Antibiotic Nasal Saline Rinse
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Vancomycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
干预措施: Vancomycin (Drug)
结局指标
主要结局
Subjects Who Developed Antibiotic Resistance Organisms
时间窗: Post-intervention (within 21 days of intervention completion)
Number of subjects who developed new antibiotic resistance organisms measured by nasal swab of the affected sinonasal cavity and sent for stain, culture, and sensitivity.
次要结局
- Change in Patient Physical Exam as Measured by the Lund-Kennedy Endoscopic Exam Scores.(Baseline, Post-intervention (within 21 days of intervention completion))
- Change in Patient Symptoms as Measured by the Sino-Nasal Outcomes Test (SNOT-22) Survey(Baseline, Post-intervention (within 21 days of intervention completion))
研究者
Garret W. Choby
Senior Associate Consultant - Department of Otorhinolaryngology; Principal Investigator
Mayo Clinic