Efficacy of Antimicrobials in Young Children with AOM

抗菌药物对患有 AOM 的幼儿的疗效

• 批准号: 7102128
• 负责人: ALEJANDRO HOBERMAN
• 金额: $ 92万
• 依托单位: CHILDREN'S HOSP PITTSBURGH/UPMC HLTH SYS
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-06-15 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7102128
• 关键词: aging; children; clinical research

DESCRIPTION (provided by applicant): A "watchful waiting" approach for children with acute otitis media (AOM) has been the standard of care for 10 years in several European countries for children as young as 6 months of age. However, most reports endorsing watchful waiting are based on meta-analyses which include trials characterized by numerous and serious methodological limitations. AOM management guidelines jointly developed by the American Academy of Pediatrics and the American Academy of Family Physicians endorsed this "watchful waiting" approach in children 6-24 months with non-severe disease and uncertain diagnosis and in children >24 months with non-severe disease regardless of certainty of diagnosis. It remains unclear to what extent antimicrobial treatment is of benefit in young children with AOM, irrespective of the severity of their illness. It may be the case either that the "watchful waiting" approach might safely be extended to include children aged 6-23 months with severe illness and/or certain diagnosis, or on the other hand, that even children with nonsevere illness would benefit sufficiently from antimicrobial treatment to justify its use. The proposed study is designed to overcome the methodological problems of earlier studies and to address this important public health issue in the group of children (6-23 months of age) who experience the greatest impact of this common condition. 264 children will be enrolled in a randomized, placebo-controlled, double-blind clinical trial to be conducted by validated otoscopists at Children's Hospital of Pittsburgh and at an affiliated pediatric practice. Primary outcome will be assessed at the early on-therapy visit (Day 4-5) and will compare the clinical efficacy of amoxicillin-clavulanate vs. placebo. Secondary outcomes to be compared between treatment groups include: (1) clinical efficacy at the end-of-therapy visit (Day 10-12), (2) symptom burden (using 3 global scales) during each of the first 7 days of therapy and at study visits, (3) proportion of children who develop worsening symptoms before 72 hours of medication, (4) quantity of analgesic medication administered by children's parents, (5) adverse events, (6) effects on nasopharyngeal bacterial colonization, (7) tympanometric outcomes, (8) direct and indirect medical costs, and (9) parental satisfaction with therapy. We assume a minimum overall clinical cure rate of 85% for children treated with amoxicillin-clavulanate. Accordingly, a total of 120 evaluable children per treatment group will allow detection of a 15% difference from placebo (85% vs. 70%), with 80% power at a significance level of 0.05 (two-tailed). This carefully designed clinical trial in children 6-23 months will address an issue of particular concern that has not been satisfactorily addressed in previous studies, whether antimicrobial treatment along with analgesic treatment offers young children with AOM an earlier and more complete overall clinical improvement (including relief of discomfort) than analgesic treatment alone. This earlier and more complete improvement may constitute the most important benefit of antimicrobial treatment.

描述（由申请人提供）：一种急性中耳炎儿童（AOM）的“注意等待”方法在几个欧洲国家 /地区为6个月大的儿童而言，已经是10年的护理标准。但是，大多数认可注意等待的报告都是基于荟萃分析的，其中包括以许多严重的方法论上的限制为特征的试验。美国儿科学会和美国家庭医师学会共同制定的AOM管理指南认可了6-24个月患有非疾病疾病和不确定诊断的儿童的这种“警惕的等待”方法，以及在24个月患有非严重疾病的儿童中，无论诊断确定。尚不清楚抗菌治疗在多大程度上对患有AOM的幼儿有益，而与疾病的严重程度无关。可能是，“警惕的等待”方法可以安全地扩展到包括患有严重疾病和/或某些诊断的6-23个月的儿童，或者另一方面，即使患有非疾病疾病的儿童也可以从抗菌治疗中获得足够的益处，以证明其使用是合理的。拟议的研究旨在克服早期研究的方法论问题，并在儿童小组（6-23个月大）中解决这一重要的公共卫生问题，他们经历了这种常见状况的最大影响。 264名儿童将在匹兹堡儿童医院和附属的儿科实践中，将参加一项随机，安慰剂对照，双盲临床试验。主要结局将在早期的治疗访问（第4-5天）进行评估，并将比较阿莫西林 - 克拉夫酸与安慰剂的临床疗效。 Secondary outcomes to be compared between treatment groups include: (1) clinical efficacy at the end-of-therapy visit (Day 10-12), (2) symptom burden (using 3 global scales) during each of the first 7 days of therapy and at study visits, (3) proportion of children who develop worsening symptoms before 72 hours of medication, (4) quantity of analgesic medication administered by children's parents, (5) adverse events, (6) effects在鼻咽细菌定殖，（7）鼓膜测量结果，（8）直接和间接的医疗费用以及（9）父母对治疗的满意度。我们假设接受阿莫西林 - 克拉酸治疗的儿童的总体临床治疗率最低为85％。因此，每个治疗组共有120名可评估的儿童可检测到与安慰剂的15％差异（85％比70％），其80％功率的显着性水平为0.05（两尾）。在6-23个月的儿童中精心设计的临床试验将解决一个特别关注的问题，在先前的研究中尚未令人满意地解决，抗菌治疗以及止痛治疗是否为单独镇痛治疗提供了更早，更完整的整体临床改善（包括缓解不适）的幼儿。这种早期，更完整的改进可能构成抗菌治疗的最重要好处。