[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649360":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":45,"centralContacts":49,"locations":55,"responsibleParty":133,"collaborators":137,"id":140,"slug":141,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":142,"sex":147,"minAge":148,"maxAge":149,"enrollmentInfo":150,"targetDuration":34,"studyType":153,"phases":154,"briefSummary":156,"conditions":157,"keywords":160,"overallStatus":162,"whyStopped":34,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8,14,19,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Amoxicillin","ACTIVE_COMPARATOR","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.",[13],"Drug: Amoxicillin",{"label":15,"type":10,"description":16,"interventionNames":17},"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.",[18],"Drug: Amoxi Clavulanate",{"label":20,"type":21,"description":22,"interventionNames":23},"Amoxicillin Placebo","PLACEBO_COMPARATOR","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.",[24],"Drug: Amoxicillin Placebo",{"label":26,"type":21,"description":22,"interventionNames":27},"Amoxicillin-Clavulanate Placebo",[28],"Drug: Amoxicillin-Clavulanate Placebo",[30,35,39,42],{"type":31,"name":9,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Amoxicillin administered orally at protocol-specified, weight-based dosing consistent with standard pediatric treatment guidelines for AS, for the defined treatment duration.",[9],null,{"type":31,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"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.",[15],{"type":31,"name":20,"description":40,"armGroupLabels":41,"otherNames":34},"Matching placebo administered orally according to the same dosing schedule and treatment duration as the active comparator arms",[20],{"type":31,"name":26,"description":43,"armGroupLabels":44,"otherNames":34},"Matching placebo administered orally according to the same dosing schedule and treatment duration as the active comparator arms.",[26],[46],{"name":47,"affiliation":5,"role":48},"Nader Shaikh, MD","PRINCIPAL_INVESTIGATOR",[50],{"name":51,"role":52,"phone":53,"phoneExt":34,"email":54},"Jane Luce, MPH","CONTACT","412-383-7853","lucej2@upmc.edu",[56,74,89,104,118],{"facility":57,"status":34,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"University of Colorado, Denver","Denver","Colorado","80204","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-104.9847,39.73915,{"lat":67,"lon":66},[70],{"name":71,"role":52,"phone":72,"phoneExt":34,"email":73},"Sean O'Leary, MD","303-724-1582","sean.oleary@cuanschutz.edu",{"facility":75,"status":34,"city":76,"state":77,"zip":78,"country":61,"countryCode":62,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Duke University Hospital","Durham","North Carolina","27705",{"type":64,"coordinates":80},[81,82],-78.89862,35.99403,{"lat":82,"lon":81},[85],{"name":86,"role":52,"phone":87,"phoneExt":34,"email":88},"Charles Wood, MD","919-620-4772","charles.wood@duke.edu",{"facility":90,"status":34,"city":91,"state":92,"zip":93,"country":61,"countryCode":62,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Cincinnati Children's Hospital","Cincinnati","Ohio","45229",{"type":64,"coordinates":95},[96,97],-84.51439,39.12711,{"lat":97,"lon":96},[100],{"name":101,"role":52,"phone":102,"phoneExt":34,"email":103},"Bill Brinkman, MD","513-636-2576","bill.brinkman@cchmc.org",{"facility":105,"status":34,"city":106,"state":107,"zip":108,"country":61,"countryCode":62,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"UPMC Children's Hospital of Pittsburgh","Pittsburgh","Pennsylvania","15213",{"type":64,"coordinates":110},[111,112],-79.99589,40.44062,{"lat":112,"lon":111},[115],{"name":47,"role":52,"phone":116,"phoneExt":34,"email":117},"412-692-8111","Nader.Shaikh@chp.edu",{"facility":119,"status":34,"city":120,"state":121,"zip":122,"country":61,"countryCode":62,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Seattle Children's Hospital","Seattle","Washington","98105",{"type":64,"coordinates":124},[125,126],-122.33207,47.60621,{"lat":126,"lon":125},[129],{"name":130,"role":52,"phone":131,"phoneExt":34,"email":132},"Douglas Opel, MD","206-987-6894","douglas.opel@seattlechildrens.org",{"type":134,"investigatorFullName":135,"investigatorTitle":136,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"SPONSOR_INVESTIGATOR","Nader Shaikh","Professor",[138],{"name":139,"class":6},"Patient-Centered Outcomes Research Institute","100649360","phase-4-comparative-effectiveness-of-available-treatments-for-sinus-and-ear-infections-in-children-acute-sinusitis-100649360",false,"NCT07732699","Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Sinusitis)","MEASURE","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.","ALL","2 Years","12 Years",{"count":151,"type":152},1100,"ESTIMATED","INTERVENTIONAL",[155],"PHASE4","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.",[158,159],"ACUTE SINUSITIS","Sinusitis",[161,159],"Pediatric Sinusitis","NOT_YET_RECRUITING","2026-07-23",{"date":165,"type":166},"2026-07-29","ACTUAL",{"date":168,"type":152},"2026-10-01",{"date":170,"type":152},"2032-03-17",{"name":135,"class":6},5]