Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Otitis Media)
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,100
- 试验地点
- 5
- 主要终点
- Average Daily Symptom Burden
研究概览
简要总结
This study is being conducted at multiple hospitals and clinics to better understand whether antibiotics truly help children feel better when they have an ear infection (acute otitis media). Children in the study are randomly assigned (like flipping a coin) to receive either amoxicillin, amoxicillin-clavulanate, or a placebo (a look-alike medicine with no active antibiotic). Neither families nor study staff know which treatment the child is receiving during the study. The main goal is to compare how severe children's symptoms are each day while on these treatments. Parents or caregivers will report symptoms daily using a simple electronic diary. The study will also look at whether certain factors such as how sick the child is at the start, presence of fever, age, or how well antibiotics work. The results will help guide better treatment decisions for children with ear infections.
详细描述
This is a multi-center, randomized, double-blind, placebo-controlled study designed to better understand whether the choice of antibiotic affects symptom burden in children with acute otitis media (AOM). Children enrolled in the study are randomly assigned to receive amoxicillin, amoxicillin-clavulanate, or a matching placebo. Neither the families nor the study team know which treatment a child is receiving during the study period. The primary objective is to compare average daily symptom severity across treatment groups using validated caregiver-reported symptom scales collected through daily electronic diaries. Analyses will account for baseline symptom severity and a combined fever/age category (temperature ≥38.5°C or age <12 months). The goal is to provide rigorous, comparative evidence on antibiotic use in this common pediatric infection to support more informed clinical decision-making and responsible antimicrobial prescribing. The study will also look at whether certain factors such as how sick the child is at the start, presence of fever, age, and how well antibiotics work. The results will help guide better treatment decisions for children with ear infections.
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
- 6 Months 至 36 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 months to <36 months.
- •Clinical diagnosis of AOM.
排除标准
- •Known allergy or other contraindication to oral amoxicillin or clavulanate
- •Prior use of systemic antibiotics in the last 7 days
- •History of renal impairment
- •History of hepatic impairment
- •Phenylketonuria or allergy to aspartame
- •History of craniofacial abnormalities
- •Concurrent bacterial infection requiring systemic antibiotic therapy (e.g., pneumonia, streptococcal pharyngitis)
- •Ill appearance, systemic toxicity, or immunodeficiency
- •Incomplete pneumococcal vaccination, defined as receipt of fewer than three doses of a pneumococcal conjugate vaccine
- •Parent or caregiver unable to complete study surveys in English or Spanish
- •Previous randomization into either MEASURE trial within the last 6 months
- •Mastoiditis
- •Conjunctivitis
- •Temperature ≥39°C and AOM-SOS score ≥35
- •Cochlear implants
- •Spontaneous tympanic membrane perforation with otorrhea at presentation (participants who develop perforation and otorrhea after consent remain eligible)
结局指标
主要结局
Average Daily Symptom Burden
时间窗: Days 1-10
Symptom burden measured daily using the Acute Otitis Media Severity of Symptoms Scale (AOM-SOS Version 6.0). AOM-SOS scores range from 0 to 50, with higher scores indicating worse symptoms. Daily scores are averaged over Days 1-10
次要结局
- Safety Outcome: Diarrhea(Randomization through Day 10)
- Recurrence of Acute Sinusitis or Acute Otitis Media(Days 11-90)
研究者
Nader Shaikh
Professor
University of Pittsburgh