[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07730814":3,"trial-entities:NCT07730814":194,"trial-summary:NCT07730814":198},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":47,"secondary_outcomes":52,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":64,"eligibility_criteria":65,"std_ages":87,"locations":89,"central_contacts":159,"overall_officials":164,"references":167,"see_also_links":193},"NCT07730814","STUDY26010103 (AOM)","Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Otitis Media)","NOT_YET_RECRUITING","2032-03-17","2026-07","2026-07-28","2026-10-01","Nader Shaikh","OTHER",true,"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.","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\u002Fage category (temperature ≥38.5°C or age \\\u003C12 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.",[18],"Acute Otitis Media (AOM)",[20,21,22],"Ear Infection","AOM","Acute Otitis Media","INTERVENTIONAL","TREATMENT",[26],"PHASE4",{"count":28,"type":29},1100,"ESTIMATED",[31,36,40,44],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Amoxicillin","Amoxicillin administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AOM, for the defined treatment duration.",[33],{"type":32,"name":37,"description":38,"armGroupLabels":39},"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.",[37],{"type":32,"name":41,"description":42,"armGroupLabels":43},"Amoxicillin Placebo","Matching placebo administered orally according to the same dosing schedule and treatment duration as the active comparator arms",[41],{"type":32,"name":45,"description":42,"armGroupLabels":46},"Amoxicillin-Clavulanate Placebo",[45],[48],{"measure":49,"description":50,"timeFrame":51},"Average Daily Symptom Burden","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",[53,57],{"measure":54,"description":55,"timeFrame":56},"Safety Outcome: Diarrhea","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",{"measure":58,"description":59,"timeFrame":60},"Recurrence of Acute Sinusitis or Acute Otitis Media","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","ALL","6 Months","36 Months",false,{"inclusion":66,"exclusion":69,"raw_text":86},[67,68],"Age 6 months to \\\u003C36 months.","Clinical diagnosis of AOM.",[70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85],"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)","Inclusion Criteria\n\n* Age 6 months to \\\u003C36 months.\n* Clinical diagnosis of AOM.\n\nExclusion Criteria\n\n* Known allergy or other contraindication to oral amoxicillin or clavulanate\n* Prior use of systemic antibiotics in the last 7 days\n* History of renal impairment\n* History of hepatic impairment\n* Phenylketonuria or allergy to aspartame\n* History of craniofacial abnormalities\n* Concurrent bacterial infection requiring systemic antibiotic therapy (e.g., pneumonia, streptococcal pharyngitis)\n* Ill appearance, systemic toxicity, or immunodeficiency\n* Incomplete pneumococcal vaccination, defined as receipt of fewer than three doses of a pneumococcal conjugate vaccine\n* Parent or caregiver unable to complete study surveys in English or Spanish\n* Previous randomization into either MEASURE trial within the last 6 months\n* Mastoiditis\n* Conjunctivitis\n* Temperature ≥39°C and AOM-SOS score ≥35\n* Cochlear implants\n* Spontaneous tympanic membrane perforation with otorrhea at presentation (participants who develop perforation and otorrhea after consent remain eligible)",[88],"CHILD",[90,105,118,131,146],{"facility":91,"city":92,"state":93,"zip":94,"country":95,"contacts":96,"geoPoint":102},"University of Colorado, Denver","Denver","Colorado","80204","United States",[97],{"name":98,"role":99,"phone":100,"email":101},"Sean O'Leary, MD","CONTACT","303-724-1582","sean.oleary@cuanschutz.edu",{"lat":103,"lon":104},39.73915,-104.9847,{"facility":106,"city":107,"state":108,"zip":109,"country":95,"contacts":110,"geoPoint":115},"Duke University Hospital","Durham","North Carolina","27705",[111],{"name":112,"role":99,"phone":113,"email":114},"Charles Wood, MD","919-620-4772","charles.wood@duke.edu",{"lat":116,"lon":117},35.99403,-78.89862,{"facility":119,"city":120,"state":121,"zip":122,"country":95,"contacts":123,"geoPoint":128},"Cincinnati Children's Hospital","Cincinnati","Ohio","45229",[124],{"name":125,"role":99,"phone":126,"email":127},"Bill Brinkman, MD","513-636-2576","bill.brinkman@cchmc.org",{"lat":129,"lon":130},39.12711,-84.51439,{"facility":132,"city":133,"state":134,"zip":135,"country":95,"contacts":136,"geoPoint":143},"UPMC Children's Hospital of Pittsburgh","Pittsburgh","Pennsylvania","15213",[137,141],{"name":138,"role":99,"phone":139,"email":140},"Nader Shaikh, MD","412-692-8111","Nader.Shaikh@chp.edu",{"name":138,"role":142},"PRINCIPAL_INVESTIGATOR",{"lat":144,"lon":145},40.44062,-79.99589,{"facility":147,"city":148,"state":149,"zip":150,"country":95,"contacts":151,"geoPoint":156},"Seattle Children's Hospital","Seattle","Washington","98105",[152],{"name":153,"role":99,"phone":154,"email":155},"Douglas Opel, MD","2069876894","douglas.opel@seattlechildrens.org",{"lat":157,"lon":158},47.60621,-122.33207,[160],{"name":161,"role":99,"phone":162,"email":163},"Jane Luce, MPH","412-383-7853","lucej2@upmc.edu",[165],{"name":138,"affiliation":166,"role":142},"University of Pittsburgh",[168,172,175,178,181,184,187,190],{"pmid":169,"type":170,"citation":171},"26099233","BACKGROUND","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\u002F14651858.CD000219.pub4.",{"pmid":173,"type":170,"citation":174},"21226576","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\u002FNEJMoa0912254.",{"pmid":176,"type":170,"citation":177},"15450120","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\u002F1477-7525-2-55.",{"pmid":179,"type":170,"citation":180},"20730626","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\u002Fs11136-010-9730-5. Epub 2010 Aug 22.",{"pmid":182,"type":170,"citation":183},"14616041","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\u002F1539-4409(2003)0032.0.co;2.",{"pmid":185,"type":170,"citation":186},"38961165","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\u002Fs41390-024-03390-2. Epub 2024 Jul 3.",{"pmid":188,"type":170,"citation":189},"31561959","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\u002Fj.jpeds.2019.08.043. Epub 2019 Sep 24.",{"pmid":191,"type":170,"citation":192},"23439909","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\u002Fpeds.2012-3488. Epub 2013 Feb 25.",[],{"nct_id":4,"conditions":195,"biomarkers":197},[196],"Acute otitis media",[],{"nct_id":4,"found":14,"summary":199,"prompt_version":209},{"design":200,"status":201,"heading":202,"summary":203,"follow_up":204,"word_count":205,"commitments":206,"compensation":207,"drugs_mentioned":208},"This is a multi-center, randomized, double-blind study with 1100 planned participants. Children will receive either amoxicillin, amoxicillin-clavulanate, or a matching placebo.","completed","Study on Treatments for Ear Infections in Children","This study is looking at how well different treatments work for ear infections (acute otitis media or AOM) in children aged 6 months to under 3 years old. We want to see if antibiotics like amoxicillin or amoxicillin-clavulanate help children feel better compared to a placebo (a look-alike medicine with no active antibiotic). You or your child would be randomly assigned to one of these treatments. Neither you nor the study team will know which treatment your child is receiving. We will ask you to report your child's symptoms daily for 10 days to see how much their symptoms improve. This helps us understand the best ways to treat ear infections.","The main symptoms are measured daily for 10 days after starting treatment.",111,"Parents or caregivers will report their child's symptoms daily using an electronic diary for 10 days.","Not stated in the trial record.",[33,37],"v2"]