Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Otitis Media)

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Amoxicillin
  Amoxicillin administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AOM, for the defined treatment duration.
• Препарат Amoxicillin-Clavulanate
  Amoxicillin-clavulanate administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AOM, for the defined treatment duration.
• Препарат Amoxicillin Placebo
  Matching placebo administered orally according to the same dosing schedule and treatment duration as the active comparator arms
• Препарат Amoxicillin-Clavulanate Placebo
  Matching placebo administered orally according to the same dosing schedule and treatment duration as the active comparator arms

Первичные конечные точки

• Average Daily Symptom Burden [Срок оценки: Days 1-10]

Вторичные конечные точки (2)

• Safety Outcome: Diarrhea [Срок оценки: Randomization through Day 10]
• Recurrence of Acute Sinusitis or Acute Otitis Media [Срок оценки: Days 11-90]

Критерии участия

Критерии включения

• Age 6 months to <36 months.
• Clinical diagnosis of AOM.

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 5 центров

• University of Colorado, Denver — Denver
• Duke University Hospital — Durham
• Cincinnati Children's Hospital — Cincinnati
• UPMC Children's Hospital of Pittsburgh — Pittsburgh
• Seattle Children's Hospital — Seattle

Публикации

• 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. PMID 26099233
• 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. PMID 21226576
• 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. PMID 15450120
• 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. PMID 20730626
• 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. PMID 14616041
• 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. PMID 38961165
• 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. PMID 31561959
• 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. PMID 23439909

Идентификаторы

NCT: NCT07730814 · STUDY26010103 (AOM) · PLACER-2024C3-42497

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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