Clinical Trial of the Treatment of Acute Sinusitis With Standard-dose Versus High-dose Amoxicillin/Clavulanate
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 315
- 试验地点
- 1
- 主要终点
- Subjective Improvement - Day 3 (Rating of "a Lot Better" or "no Symptoms")
研究概览
简要总结
The aim is to determine if high-dose amoxicillin/clavulanate is more effective than standard-dose amoxicillin/clavulanate in treating acute bacterial sinusitis in adults seen at a primary care office.
详细描述
The aim was amended in February 2016--because of the unexpected unavailability of the original high-dose formulation of amoxicillin/clavulanate--to compare the effectiveness (versus standard dose) of extended-release (the original formulation) versus immediate-release amoxicillin/clavulanate.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult 18 or over
- •Meets definition of acute sinusitis by Infectious Disease Society of America (2012)
- •Clinician and participant chose to start antibiotic treatment
排除标准
- •Previously enrolled in the study
- •Allergic or intolerant to amoxicillin, penicillin, or amoxicillin/clavulanate
- •Specific medication concerns: lactating (since safety of clavulanate unknown); taking allopurinol (increased risk of rash); concurrent mononucleosis (increased risk of rash with amoxicillin); chronic kidney disease with glomerular filtration rate < 30; significant hepatic impairment; history of antibiotic-associated colitis
- •Cognitive impairment so that unable to give informed consent or give reliable assessment of improvement
- •Need to use high-dose amoxicillin/clavulanate: treatment with amoxicllin or penicillin within the past month (risk of penicillin-resistant pneumococci), very ill patient (though not ill enough to send to hospital); immunocompromise
- •Need to hospitalize the patient
研究组 & 干预措施
standard dose
amoxicillin/clavulanate 875/125 mg + placebo tablet twice a day for 7 days
干预措施: standard dose amoxicillin/clavulanate (Drug)
high dose
Time Period I (November 18, 2014-January 5, 2016): extended-release amoxicillin/clavulanate 1000/62.5 mg 2 tablets (by different manufacturer) twice a day for 7 days Time Period 2 (February 6, 2016-February 27, 2017): immediate-release amoxicillin/clavunate 875/125 mg plus standard immediate-release amoxicillin 875 mg twice a day for 7 days
干预措施: high dose amoxicillin/clavulanate (Drug)
结局指标
主要结局
Subjective Improvement - Day 3 (Rating of "a Lot Better" or "no Symptoms")
时间窗: end of 3 days of treatment
rating of "a lot better" or "no symptoms"
次要结局
- SNOT-16 - Day 3(day 0, end of 3 days of treatment)
- Subjective Improvement - Day 10(end of 10th day)
- SNOT-16 - Day 10(day 0, end of 10th day)
- Nasal Colonization With Resistant Bacteria(baseline)
- Willingness to Take the Study Antibiotic in the Future(end of 10th day)
研究者
Paul Sorum, MD
Professor of Internal Medicine and Pediatrics
Albany Medical College