Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course)
研究概览
简要总结
The investigators objective is to compare short course (5 days) to long course (14 days)antibiotics for the treatment of acute bacterial sinusitis in children. The investigators hypothesize that short course therapy will lead to more frequent relapses of sinusitis and will not reduce resistant organisms.
详细描述
This was a prospective, randomized, double-blind study comparing short course (5 days) to long course (14 days) antimicrobial therapy for children between 1 and 10 years of age with acute bacterial sinusitis. The major outcome measure is the proportion of children with a clinical relapse on day 10 in the short course therapy group compared to day 20 in the long course therapy group. In addition, the proportion of respiratory flora that are resistant to antibiotics on day 30 will be compared to baseline in each group.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children with nasal discharge (of any quality) or daytime cough (which may be worse at night) or both persisting for 10 days or more without evidence of improvement.
- •families need to be English speaking
排除标准
- •used antibiotics within the last 15 days;
- •had symptoms for > 30 days;
- •have concurrent streptococcal pharyngitis or acute otitis media (as the standard doses for both of these conditions is 10 days);
- •are allergic to penicillin;
- •have symptoms that suggest a complication due to acute bacterial sinusitis that necessitates hospitalization, intravenous antibiotics or sub-specialty evaluation
- •been diagnosed with either immunodeficiency or anatomic abnormality of the upper respiratory tract
- •history of recurrent acute sinusitis (more than 3 episodes in 6 months or 4 episodes in a year)
- •history of chronic sinusitis (more than 90 days of respiratory symptoms in this or the previous respiratory season)
- •girls who have begun menstruating
研究组 & 干预措施
Short Course
Short course (5 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination and placebo for next 9 days.
干预措施: Amoxicillin-Potassium Clavulanate Combination (Drug)
Short Course
Short course (5 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination and placebo for next 9 days.
干预措施: Placebo (Drug)
Long Course
Long course (14 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination given orally for 14 days.
干预措施: Amoxicillin-Potassium Clavulanate Combination (Drug)
结局指标
主要结局
Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course)
时间窗: at 10 days and at 20 days
Results are based on a daily 6-item symptom survey (day 1 to 14); a daily 3-item survey (day 15 to 30). If a particular symptom is present initially, a score of 2 is given; if it is absent the score is 0. A maximum entry score is 20 (persistent symptoms). If a particular symptom becomes more severe, less severe, or stays the same during treatment, +1, -1, or 0 respectively, will be added to the original score for each symptom. At 10 (and 20 days, respectively), children will be classified as cured, improved or failed based on survey results. Children will be considered cured if they reach a score of \< 2. Children will be classified as improved if their score at 10 days (20 days, respectively) is at least 2 points less than their score at 5 days (15 days, respectively). Children will be considered to have failed therapy if their score worsens by + 3 between day 5 (day 15) and day 10 (day 20) or if their score at day 10 (day 20) does not meet criteria for improvement.
次要结局
- Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline(Baseline and 30 days)