A Randomized Cohort Trial Evaluating Duration of Antibiotic Therapy as Part of Maximal Medical Therapy for Chronic Rhinosinusitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Patients Recommended for Sinus Surgery After 3 Weeks of Antibiotic Therapy
研究概览
简要总结
The purpose of this study is to determine the best duration(3 versus 6 weeks) of antibiotics as part of maximal medical therapy for treating chronic sinusitis and thus preventing patients from having to have sinus surgery. The hypothesis is that in the context of maximal medical therapy 3 weeks of antibiotics is not worse than 6 weeks of antibiotics at successfully treating chronic sinusitis.
详细描述
OVERVIEW This is a prospective randomized cohort study assessing duration of antibiotics (3 vs 6 weeks) as part of maximal medical therapy for chronic rhinosinusitis. Up to 100 subjects will be prospectively enrolled from patients visiting the Department of Otolaryngology-Head and Neck Surgery clinics at UNC Hospitals.
INITIAL CLINIC VISIT At the time of a clinical visit, the attending otolaryngologists will identify their patients with chronic rhinosinusitis (CRS) who are appropriate for maximal medical treatment, including antibiotics. They will introduce the study to these patients and invite them to learn more about it.
If the patient is interested in learning more about the study, the study coordinators will be contacted to provide additional information and, if the patient would like to participate in the study, provide informed consent.
If the patient is a premenopausal woman, she will be asked if she is pregnant or breastfeeding.
If she is either of these, she will be excluded from the study. All remaining women will receive a urine pregnancy test. If this urine pregnancy test is positive, the patient will be excluded from the study. Thus, for premenopausal female patients, a negative urine pregnancy test is necessary for inclusion in the study. These women will be informed that they should use an effective method of birth control during the study:
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic rhinosinusitis
- •18 years of age or older
- •English speaking
排除标准
- •Pregnant or breastfeeding women
- •vasculitis
- •cystic fibrosis
- •primary ciliary dyskinesia
- •allergic fungal sinusitis
- •gross immunodeficiency
- •current use of chemotherapy
- •insulin-dependent diabetes mellitus
- •recent trial of maximal medical therapy
研究组 & 干预措施
Azithromycin, 3 weeks
Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration.
干预措施: Azithromycin (Drug)
Doxycycline, 3 weeks
Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.
干预措施: Doxycycline (Drug)
Doxycycline, 3 weeks
Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.
干预措施: Augmentin (Drug)
Doxycycline, 6 weeks
Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 6 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.
干预措施: Doxycycline (Drug)
Doxycycline, 6 weeks
Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 6 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.
干预措施: Augmentin (Drug)
Azithromycin, 3 weeks
Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration.
干预措施: Augmentin (Drug)
Azithromycin, 6 weeks
Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration.
干预措施: Azithromycin (Drug)
Azithromycin, 6 weeks
Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration.
干预措施: Augmentin (Drug)
结局指标
主要结局
Number of Patients Recommended for Sinus Surgery After 3 Weeks of Antibiotic Therapy
时间窗: 4-5 weeks after starting antibiotics
Recommendation for sinus surgery after completion of maximal medical therapy is determined by the subject's treating physician and is based on two citeria: (1) persistence of symptoms and (2) objective evidence of disease on post-treatment sinus CT scan or nasal endoscopy. Symptomatic improvement of sinusitis symptoms will be assessed by: patient self report, change in Chronic Sinusitis Survery (CSS) score and change in RhinoSinusitis Disibility Index (RSDI) score relative to initial pre-antibiotic CSS and RSDI survey scores.
Number of Patients Recommended for Sinus Surgery After 6 Weeks of Antibiotic Therapy
时间窗: 7-8 weeks after initiating antibiotics
Recommendation for sinus surgery after completion of maximal medical therapy is determined by the subject's treating physician and is based on two citeria: (1) persistence of symptoms and (2) objective evidence of disease on post-treatment sinus CT scan or nasal endoscopy. Symptomatic improvement of sinusitis symptoms will be assessed by: patient self report, change in Chronic Sinusitis Survery (CSS) score and change in RhinoSinusitis Disibility Index (RSDI) score relative to initial pre-antibiotic CSS and RSDI survey scores.
次要结局
未报告次要终点
研究者
Adam Zanation, MD
Assistant Professor of Otolaryngology/Head and Neck Surgery
University of North Carolina, Chapel Hill