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

Обзор

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.

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 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

Вмешательства

• Препарат Amoxicillin
  Amoxicillin administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AS, for the defined treatment duration.
• Препарат Amoxi Clavulanate
  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.
• 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 2 years to <12 years.
• Clinical diagnosis of AS.

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
• 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.

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

• 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. PMID 23796742
• 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
• 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
• 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. PMID 37490085
• 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
• 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. PMID 30545562

Идентификаторы

NCT: NCT07732699 · STUDY26010103 (AS) · PLACER-2024C3-42497

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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