[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07732699":3,"trial-entities:NCT07732699":185,"trial-summary:NCT07732699":189},{"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":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":48,"secondary_outcomes":53,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":65,"eligibility_criteria":66,"std_ages":85,"locations":87,"central_contacts":155,"overall_officials":160,"references":164,"see_also_links":184},"NCT07732699","STUDY26010103 (AS)","Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Sinusitis)","NOT_YET_RECRUITING","2032-03-17","2026-07","2026-07-29","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 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.","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",[18,19],"ACUTE SINUSITIS","Sinusitis",[21,19],"Pediatric Sinusitis","INTERVENTIONAL","TREATMENT",[25],"PHASE4",{"count":27,"type":28},1100,"ESTIMATED",[30,35,40,44],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","Amoxicillin","Amoxicillin administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AS, for the defined treatment duration.",[32],{"type":31,"name":36,"description":37,"armGroupLabels":38},"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.",[39],"Amoxicillin-Clavulanate",{"type":31,"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":31,"name":45,"description":46,"armGroupLabels":47},"Amoxicillin-Clavulanate Placebo","Matching placebo administered orally according to the same dosing schedule and treatment duration as the active comparator arms.",[45],[49],{"measure":50,"description":51,"timeFrame":52},"Average Daily Symptom Burden","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","Days 1-10",[54,58],{"measure":55,"description":56,"timeFrame":57},"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":59,"description":60,"timeFrame":61},"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","2 Years","12 Years",false,{"inclusion":67,"exclusion":70,"raw_text":84},[68,69],"Age 2 years to \\\u003C12 years.","Clinical diagnosis of AS.",[71,72,73,74,75,76,77,78,79,80,81,82,83],"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\u002For 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.","Inclusion Criteria:\n\n* Age 2 years to \\\u003C12 years.\n* Clinical diagnosis of AS.\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* Periorbital redness and\u002For swelling, proptosis, or swelling of the forehead\n* Individuals who qualify for both the AS and AOM trials (to avoid dual enrollment) will be excluded from the AS trial.",[86],"CHILD",[88,103,116,129,142],{"facility":89,"city":90,"state":91,"zip":92,"country":93,"contacts":94,"geoPoint":100},"University of Colorado, Denver","Denver","Colorado","80204","United States",[95],{"name":96,"role":97,"phone":98,"email":99},"Sean O'Leary, MD","CONTACT","303-724-1582","sean.oleary@cuanschutz.edu",{"lat":101,"lon":102},39.73915,-104.9847,{"facility":104,"city":105,"state":106,"zip":107,"country":93,"contacts":108,"geoPoint":113},"Duke University Hospital","Durham","North Carolina","27705",[109],{"name":110,"role":97,"phone":111,"email":112},"Charles Wood, MD","919-620-4772","charles.wood@duke.edu",{"lat":114,"lon":115},35.99403,-78.89862,{"facility":117,"city":118,"state":119,"zip":120,"country":93,"contacts":121,"geoPoint":126},"Cincinnati Children's Hospital","Cincinnati","Ohio","45229",[122],{"name":123,"role":97,"phone":124,"email":125},"Bill Brinkman, MD","513-636-2576","bill.brinkman@cchmc.org",{"lat":127,"lon":128},39.12711,-84.51439,{"facility":130,"city":131,"state":132,"zip":133,"country":93,"contacts":134,"geoPoint":139},"UPMC Children's Hospital of Pittsburgh","Pittsburgh","Pennsylvania","15213",[135],{"name":136,"role":97,"phone":137,"email":138},"Nader Shaikh, MD","412-692-8111","Nader.Shaikh@chp.edu",{"lat":140,"lon":141},40.44062,-79.99589,{"facility":143,"city":144,"state":145,"zip":146,"country":93,"contacts":147,"geoPoint":152},"Seattle Children's Hospital","Seattle","Washington","98105",[148],{"name":149,"role":97,"phone":150,"email":151},"Douglas Opel, MD","206-987-6894","douglas.opel@seattlechildrens.org",{"lat":153,"lon":154},47.60621,-122.33207,[156],{"name":157,"role":97,"phone":158,"email":159},"Jane Luce, MPH","412-383-7853","lucej2@upmc.edu",[161],{"name":136,"affiliation":162,"role":163},"University of Pittsburgh","PRINCIPAL_INVESTIGATOR",[165,169,172,175,178,181],{"pmid":166,"type":167,"citation":168},"23796742","BACKGROUND","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\u002Fpeds.2013-1071.",{"pmid":170,"type":167,"citation":171},"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":173,"type":167,"citation":174},"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":176,"type":167,"citation":177},"37490085","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\u002Fjama.2023.10854.",{"pmid":179,"type":167,"citation":180},"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":182,"type":167,"citation":183},"30545562","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\u002Fj.jpeds.2018.11.016. Epub 2018 Dec 10.",[],{"nct_id":4,"conditions":186,"biomarkers":188},[187],"Acute Sinusitis",[],{"nct_id":4,"found":14,"summary":190,"prompt_version":200},{"design":191,"status":192,"heading":193,"summary":194,"follow_up":195,"word_count":196,"commitments":197,"compensation":198,"drugs_mentioned":199},"This is a multi-center, randomized, double-blind, placebo-controlled study with a planned enrollment of 1100 participants.","completed","Comparing Treatments for Sinus and Ear Infections in Children","This study is comparing how well different treatments work for children aged 2 to 12 years with acute sinusitis (a sinus infection). You or your child would receive either amoxicillin, amoxicillin-clavulanate, or a placebo (a look-alike medicine without active antibiotic). Neither you nor the study staff will know which treatment is given. The main goal is to see how much children's symptoms improve each day over 10 days. We are looking for 1100 participants. The study status is currently unclear.","Participants are followed for 10 days, based on the primary endpoint time-frame.",80,"Parents or caregivers will report symptoms daily using a simple electronic diary for 10 days.","Not stated in the trial record.",[32],"v2"]