Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Otitis Media) (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 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.
調査の概要
状態
まだ募集していません
条件
詳細な説明
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 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.
研究の種類
介入
入学 (推定)
1100
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Jane Luce, MPH
- 電話番号：412-383-7853
- メール：lucej2@upmc.edu
研究場所
-
-
Colorado
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Denver、Colorado、アメリカ、80204
- University of Colorado, Denver
-
コンタクト：
- Sean O'Leary, MD
- 電話番号：303-724-1582
- メール：sean.oleary@cuanschutz.edu
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North Carolina
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Durham、North Carolina、アメリカ、27705
- Duke University Hospital
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コンタクト：
- Charles Wood, MD
- 電話番号：919-620-4772
- メール：charles.wood@duke.edu
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Ohio
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Cincinnati、Ohio、アメリカ、45229
- Cincinnati Children's Hospital
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コンタクト：
- Bill Brinkman, MD
- 電話番号：513-636-2576
- メール：bill.brinkman@cchmc.org
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213
- UPMC Children's Hospital of Pittsburgh
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コンタクト：
- Nader Shaikh, MD
- 電話番号：412-692-8111
- メール：Nader.Shaikh@chp.edu
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主任研究者：
- Nader Shaikh, MD
-
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Washington
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Seattle、Washington、アメリカ、98105
- Seattle Children's Hospital
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コンタクト：
- Douglas Opel, MD
- 電話番号：2069876894
- メール：douglas.opel@seattlechildrens.org
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria
- Age 6 months to <36 months.
- Clinical diagnosis of AOM.
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
- 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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Amoxicillin
Participants randomized to this arm will receive oral amoxicillin for the treatment of acute otitis media (AOM).
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 AOM, for the defined treatment duration.
|
|
アクティブコンパレータ：Amoxicillin-Clavulanate
Participants randomized to this arm will receive oral amoxicillin-clavulanate for the treatment of AOM.
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, for the defined treatment duration.
|
|
プラセボコンパレーター：Amoxicillin Placebo
Participants randomized to this arm will receive a matching oral placebo for the treatment of AOM.
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
|
|
プラセボコンパレーター：Amoxicillin-Clavulanate Placebo
Participants randomized to this arm will receive a matching oral placebo for the treatment of AOM.
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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Average Daily Symptom Burden
時間枠：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
|
Days 1-10
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Safety Outcome: Diarrhea
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Nader Shaikh, MD、University of Pittsburgh
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
- Shaikh N, Lee MC, Kurs-Lasky M. Modification of an outcome measure to follow symptoms of children with acute otitis media. Pediatr Res. 2025 Feb;97(2):695-699. doi: 10.1038/s41390-024-03390-2. Epub 2024 Jul 3.
- Venekamp RP, Sanders SL, Glasziou PP, Del Mar CB, Rovers MM. Antibiotics for acute otitis media in children. Cochrane Database Syst Rev. 2015 Jun 23;2015(6):CD000219. doi: 10.1002/14651858.CD000219.pub4.
- Hoberman A, Paradise JL, Rockette HE, Shaikh N, Wald ER, Kearney DH, Colborn DK, Kurs-Lasky M, Bhatnagar S, Haralam MA, Zoffel LM, Jenkins C, Pope MA, Balentine TL, Barbadora KA. Treatment of acute otitis media in children under 2 years of age. N Engl J Med. 2011 Jan 13;364(2):105-15. doi: 10.1056/NEJMoa0912254.
- Hum SW, Shaikh KJ, Musa SS, Shaikh N. Adverse Events of Antibiotics Used to Treat Acute Otitis Media in Children: A Systematic Meta-Analysis. J Pediatr. 2019 Dec;215:139-143.e7. doi: 10.1016/j.jpeds.2019.08.043. Epub 2019 Sep 24.
- Lieberthal AS, Carroll AE, Chonmaitree T, Ganiats TG, Hoberman A, Jackson MA, Joffe MD, Miller DT, Rosenfeld RM, Sevilla XD, Schwartz RH, Thomas PA, Tunkel DE. The diagnosis and management of acute otitis media. Pediatrics. 2013 Mar;131(3):e964-99. doi: 10.1542/peds.2012-3488. Epub 2013 Feb 25.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月1日
一次修了 (推定)
2031年12月18日
研究の完了 (推定)
2032年3月17日
試験登録日
最初に提出
2026年7月23日
QC基準を満たした最初の提出物
2026年7月23日
最初の投稿 (実際)
2026年7月28日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月28日
QC基準を満たした最後の更新が送信されました
2026年7月23日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- STUDY26010103 (AOM)
- PLACER-2024C3-42497 (その他の助成金/資金番号：PCORI)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
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 共有アクセス基準
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。