Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Sinusitis) (MEASURE)
2026年7月23日 更新者：Nader Shaikh
This study is being conducted at multiple hospitals and clinics to better understand whether antibiotics truly help children feel better when they have a sinus infection (acute sinusitis).
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 examine whether factors such as the severity of the child's illness or signs of allergies affect how well antibiotics work.
The results will help guide better treatment decisions for children with sinus infections.
研究概览
地位
尚未招聘
详细说明
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 sinusitis (AS).
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 assess whether symptoms suggestive of allergy (sneezing or itchy eyes) or more severe nasal findings (such as marked congestion or perinasal crusting) influence treatment response.
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 examine whether factors such as the severity of the child's illness and signs of allergies affect how well antibiotics work.
The results will help guide better treatment decisions for children with sinus infections
研究类型
介入性
注册 (估计的)
1100
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Jane Luce, MPH
- 电话号码：412-383-7853
- 邮箱：lucej2@upmc.edu
学习地点
-
-
Colorado
-
Denver、Colorado、美国、80204
- University of Colorado, Denver
-
接触：
- Sean O'Leary, MD
- 电话号码：303-724-1582
- 邮箱：sean.oleary@cuanschutz.edu
-
-
North Carolina
-
Durham、North Carolina、美国、27705
- Duke University Hospital
-
接触：
- Charles Wood, MD
- 电话号码：919-620-4772
- 邮箱：charles.wood@duke.edu
-
-
Ohio
-
Cincinnati、Ohio、美国、45229
- Cincinnati Children's Hospital
-
接触：
- Bill Brinkman, MD
- 电话号码：513-636-2576
- 邮箱：bill.brinkman@cchmc.org
-
-
Pennsylvania
-
Pittsburgh、Pennsylvania、美国、15213
- UPMC Children's Hospital of Pittsburgh
-
接触：
- Nader Shaikh, MD
- 电话号码：412-692-8111
- 邮箱：Nader.Shaikh@chp.edu
-
-
Washington
-
Seattle、Washington、美国、98105
- Seattle Children's Hospital
-
接触：
- Douglas Opel, MD
- 电话号码：206-987-6894
- 邮箱：douglas.opel@seattlechildrens.org
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
不
描述
Inclusion Criteria:
- Age 2 years to <12 years.
- Clinical diagnosis of AS.
Exclusion Criteria:
- 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
- Periorbital redness and/or swelling, proptosis, or swelling of the forehead
- Individuals who qualify for both the AS and AOM trials (to avoid dual enrollment) will be excluded from the AS trial.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Amoxicillin
Participants randomized to this arm will receive oral amoxicillin for the treatment of acute sinusitis (AS).
Caregivers will complete daily electronic symptom diaries throughout the treatment period.
|
Amoxicillin administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AS, for the defined treatment duration.
|
|
有源比较器：Amoxicillin-Clavulanate
Participants randomized to this arm will receive oral amoxicillin-clavulanate for the treatment of AS.
Caregivers will complete daily electronic symptom diaries throughout the treatment period.
|
Amoxicillin-clavulanate administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AOM or AS, for the defined treatment duration.
|
|
安慰剂比较：Amoxicillin Placebo
Participants randomized to this arm will receive a matching oral placebo for the treatment of AS.
Caregivers will complete daily electronic symptom diaries throughout the treatment period.
|
Matching placebo administered orally according to the same dosing schedule and treatment duration as the active comparator arms
|
|
安慰剂比较：Amoxicillin-Clavulanate Placebo
Participants randomized to this arm will receive a matching oral placebo for the treatment of AS.
Caregivers will complete daily electronic symptom diaries throughout the treatment period.
|
Matching placebo administered orally according to the same dosing schedule and treatment duration as the active comparator arms.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Average Daily Symptom Burden
大体时间：Days 1-10
|
Symptom burden measured daily using the Pediatric Rhinosinusitis Symptom Scale (PRSS Version 2.0).
PRSS scores range from 0 to 40, with higher scores indicating worse symptoms.
Daily scores are averaged over Days 1-10
|
Days 1-10
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Safety Outcome: Diarrhea
大体时间：Randomization through Day 10
|
Occurrence of diarrhea, defined as at least 3 watery stools in one day or at least 2 watery stools per day on two consecutive days.
|
Randomization through Day 10
|
|
Recurrence of Acute Sinusitis or Acute Otitis Media
大体时间：Days 11-90
|
Occurrence of one or more new episodes of clinically diagnosed acute sinusitis or acute otitis media following resolution of the index episode.
|
Days 11-90
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 首席研究员：Nader Shaikh, MD、University of Pittsburgh
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Varni JW, Sherman SA, Burwinkle TM, Dickinson PE, Dixon P. The PedsQL Family Impact Module: preliminary reliability and validity. Health Qual Life Outcomes. 2004 Sep 27;2:55. doi: 10.1186/1477-7525-2-55.
- Varni JW, Burwinkle TM, Seid M, Skarr D. The PedsQL 4.0 as a pediatric population health measure: feasibility, reliability, and validity. Ambul Pediatr. 2003 Nov-Dec;3(6):329-41. doi: 10.1367/1539-4409(2003)0032.0.co;2.
- Varni JW, Limbers CA, Neighbors K, Schulz K, Lieu JE, Heffer RW, Tuzinkiewicz K, Mangione-Smith R, Zimmerman JJ, Alonso EM. The PedsQL Infant Scales: feasibility, internal consistency reliability, and validity in healthy and ill infants. Qual Life Res. 2011 Feb;20(1):45-55. doi: 10.1007/s11136-010-9730-5. Epub 2010 Aug 22.
- Wald ER, Applegate KE, Bordley C, Darrow DH, Glode MP, Marcy SM, Nelson CE, Rosenfeld RM, Shaikh N, Smith MJ, Williams PV, Weinberg ST; American Academy of Pediatrics. Clinical practice guideline for the diagnosis and management of acute bacterial sinusitis in children aged 1 to 18 years. Pediatrics. 2013 Jul;132(1):e262-80. doi: 10.1542/peds.2013-1071.
- Shaikh N, Hoberman A, Shope TR, Jeong JH, Kurs-Lasky M, Martin JM, Bhatnagar S, Muniz GB, Block SL, Andrasko M, Lee MC, Rajakumar K, Wald ER. Identifying Children Likely to Benefit From Antibiotics for Acute Sinusitis: A Randomized Clinical Trial. JAMA. 2023 Jul 25;330(4):349-358. doi: 10.1001/jama.2023.10854.
- Shaikh N, Wald ER, Jeong JH, Kurs-Lasky M, Nash D, Pichichero ME, Kearney DH, Haralam MA, Bowen A, Flom LL, Hoberman A. Development and Modification of an Outcome Measure to Follow Symptoms of Children with Sinusitis. J Pediatr. 2019 Apr;207:103-108.e1. doi: 10.1016/j.jpeds.2018.11.016. Epub 2018 Dec 10.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月1日
初级完成 (估计的)
2031年12月18日
研究完成 (估计的)
2032年3月17日
研究注册日期
首次提交
2026年7月23日
首先提交符合 QC 标准的
2026年7月23日
首次发布 (实际的)
2026年7月29日
研究记录更新
最后更新发布 (实际的)
2026年7月29日
上次提交的符合 QC 标准的更新
2026年7月23日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- STUDY26010103 (AS)
- PLACER-2024C3-42497 (其他赠款/资助编号：PCORI)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
De-identified individual participant data (IPD) underlying the results reported in publications and the final study report, including relevant data dictionaries and metadata necessary to interpret the data, will be shared in accordance with PCORI's Policy for Data Management and Data Sharing.
The shared data set will include the final cleaned and locked analyzable data set used for primary and secondary analyses reported from the study.
Data will be de-identified in accordance with applicable federal and institutional privacy requirements, including the HIPAA Privacy Rule.
Supporting documentation necessary to reproduce study findings and facilitate secondary analyses will also be made available.
IPD 共享时间框架
De-identified IPD and supporting documentation will become available after publication of the primary study results and completion of PCORI's peer review and public release process, and no later than 12 months following publication of the primary results.
Data and supporting documentation will remain available for at least seven years following study completion, consistent with PCORI policy requirements.
IPD 共享访问标准
Access to de-identified IPD and supporting documentation may be provided to qualified researchers for scientifically sound secondary research purposes, consistent with participant informed consent, institutional review board (IRB) requirements, and applicable laws and regulations.
Requests may require submission of a research proposal, statistical analysis plan, and execution of a data use agreement.
Data will be shared through a secure institutional or repository-based mechanism determined by the study team and sponsoring institution.
Access decisions will be reviewed by the study investigators and/or designated data access committee in accordance with institutional and PCORI data sharing policies.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.