Treatment of Acute Sinusitis With High-Dose vs. Standard-Dose Amoxicillin/Clavulanate: A Confirmation Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Number of Participants With a Global Rating of Improvement of 5 & 6 at the End of 3 Days of Treatment
研究概览
简要总结
Comparative-effectiveness study of the treatment of acute bacterial sinusitis with amoxicillin/clavulanate 875mg/125mg bid for 7 days with or without the addition of immediate-release amoxicillin 875 mg bid x 7 days. .
详细描述
Double-blind comparative-effectiveness study of the treatment of acute bacterial sinusitis with standard dose of amoxicillin/clavulanate 875mg/125mg bid for 7 days, as recommended by the Infectious Disease Society of America, with or without the addition of immediate-release amoxicillin 875 mg bid x 7 days. The study aims are 1) to confirm, or not, our recent findings of more rapid improvement in overall symptoms with the additional amoxicillin, but also of more frequent diarrhea and vaginal yeast infections and 2) to assess, from the participants' point of view, the balance between improvement and adverse effects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Unlabeled bottles of study medications, identified only by participant #, prepared by the pharmacist member of research team. The placebo will be similar in appearance to plain amoxicillin. The pills inside the bottle will be difficult to see until the bottle is opened by the patient.
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 18 and older who are patients at the Albany Medical Center Internal Medicine and Pediatrics practice (study site).
- •Clinical diagnosis of acute bacterial sinusitis in accordance with the guidelines of the Infectious Disease Society of America (fitting into one of 3 categories: persistent sinus symptoms for 10 days or more; severe sinus symptoms for 3 days or more; or worsening sinus symptoms after initial improvement (double sickening).
排除标准
- •Previous enrollment in the current study
- •Allergy or intolerance to any penicillin or to amoxicillin/clavulanate
- •Serious hypersensitivity reaction to any beta lactam
- •Elevated risk of amoxicillin-resistant bacteria: a. amoxicillin, penicillin, or other beta-lactam within the past month; b. known to have had methicillin-resistant Staph aureus
- •Chronic or recurrent "sinus" problems (defined as a) persistent symptoms of "sinus" congestion, not attributed to nasal allergies, for 8 weeks or more or b) 2 or more episodes of antibiotic-treated "sinusitis" in past 3 months
- •Need to use high-dose amoxicillin/clavulanate or levofloxacin or to send to emergency department or to hospitalize because of a) signs of severe infection or b) immunocompromise
- •Cognitive impairment, so unable to give reliable symptom ratings (even if a health proxy can give consent)
- •Pregnant women and nursing mothers
- •Drug warnings: a) taking allopurinol; b) current mononucleosis; c) chronic kidney disease stage 4 (estimated glomerular filtration rate <30); d) hepatic impairment (not including isolated transaminase elevated < 2 times upper limit of normal); e) history of antibiotic-associated colitis (C. difficile)
研究组 & 干预措施
High dose
Amoxicillin/clavulanate 875mg/125mg & amoxicillin 875 mg twice a day x 7 days
干预措施: Amoxicillin 875 mg (Drug)
Standard dose
Amoxicillin/clavulanate 875 mg/125mg & placebo (lactase) twice a day x 7 days.
干预措施: Placebo (lactase) (Dietary Supplement)
结局指标
主要结局
Number of Participants With a Global Rating of Improvement of 5 & 6 at the End of 3 Days of Treatment
时间窗: At end of 3 days of treatment
Rating on a scale of 1=a lot worse, 2=a little worse, 3=the same, 4=a little better, 5=a lot better, 6=no symptoms, with a higher score indicating greater improvement.
次要结局
- Change From Baseline in the Total Score on the Sinonasal Outcome Test-16 (SNOT-16) at the End of 3 Days of Treatment(At end of 3 days of treatment)
- Number of Participants With a Global Rating of Improvement of 5 or 6 at End of 10 Days Since Enrollment(At end of 10 days since enrollment)
- Change From Baseline in the Total Score on the Sinonasal Outcome Test-16 (SNOT-16) at the End of 10 Days Since Enrollment(At end of 10 days since enrollment)
- Balance of Benefits and Detriments(At end of 10 days since enrollment)
- Number of Participants Answering "Yes" to Willingness to Take the Antibiotic Again in the Future(At end of 10 days since enrollment)
研究者
Paul Sorum, MD
Professor of Internal Medicine and Pediatrics
Albany Medical College