Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Sinusitis) (MEASURE)
2026년 7월 23일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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
연구 유형
중재적
등록 (추정된)
1100
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Jane Luce, MPH
- 전화번호: 412-383-7853
- 이메일: lucej2@upmc.edu
연구 장소
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Colorado
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Denver, Colorado, 미국, 80204
- University of Colorado, Denver
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연락하다:
- Sean O'Leary, MD
- 전화번호: 303-724-1582
- 이메일: sean.oleary@cuanschutz.edu
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North Carolina
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Durham, North Carolina, 미국, 27705
- Duke University Hospital
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연락하다:
- Charles Wood, MD
- 전화번호: 919-620-4772
- 이메일: charles.wood@duke.edu
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Ohio
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Cincinnati, Ohio, 미국, 45229
- Cincinnati Children's Hospital
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연락하다:
- Bill Brinkman, MD
- 전화번호: 513-636-2576
- 이메일: bill.brinkman@cchmc.org
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15213
- UPMC Children's Hospital of Pittsburgh
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연락하다:
- Nader Shaikh, MD
- 전화번호: 412-692-8111
- 이메일: Nader.Shaikh@chp.edu
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Washington
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Seattle, Washington, 미국, 98105
- Seattle Children's Hospital
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연락하다:
- Douglas Opel, MD
- 전화번호: 206-987-6894
- 이메일: douglas.opel@seattlechildrens.org
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: 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.
|
|
활성 비교기: 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.
|
|
위약 비교기: 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
|
|
위약 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Average Daily Symptom Burden
기간: Days 1-10
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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
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Days 1-10
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Safety Outcome: Diarrhea
기간: 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.
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Randomization through Day 10
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Recurrence of Acute Sinusitis or Acute Otitis Media
기간: Days 11-90
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Occurrence of one or more new episodes of clinically diagnosed acute sinusitis or acute otitis media following resolution of the index episode.
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Days 11-90
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Nader Shaikh, MD, University of Pittsburgh
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 10월 1일
기본 완료 (추정된)
2031년 12월 18일
연구 완료 (추정된)
2032년 3월 17일
연구 등록 날짜
최초 제출
2026년 7월 23일
QC 기준을 충족하는 최초 제출
2026년 7월 23일
처음 게시됨 (실제)
2026년 7월 29일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 29일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 23일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY26010103 (AS)
- PLACER-2024C3-42497 (기타 보조금/기금 번호: PCORI)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
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 공유 기간
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 공유 액세스 기준
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .