[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554052":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":73,"centralContacts":77,"locations":86,"responsibleParty":108,"collaborators":32,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":32,"eligibilityCriteria":116,"healthyVolunteers":112,"sex":117,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":32,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":89,"whyStopped":32,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Medical College of Wisconsin","OTHER",[8,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Short course antibiotic duration","EXPERIMENTAL","The participants in this group will receive a total antibiotic course of 5 days including the number of days received during their hospital admission and following hospital admission combined.",[13,14,15,16,17,18,19,20],"Drug: Ampicillin for Injection","Drug: Ceftriaxone for Injection","Drug: Amoxicillin","Drug: Ampicillin \u002F Sulbactam Injection","Drug: Amoxicillin-clavulanate","Drug: Clindamycin","Drug: Cefprozil","Drug: Levofloxacin",{"label":22,"type":23,"description":24,"interventionNames":25},"Standard of care antibiotic duration","ACTIVE_COMPARATOR","Participants will receive the standard-of-care antibiotic course in this group. That is, the duration of antibiotics will be decided by the primary treating physician in this group. The antibiotic course will include the number of days received during the participant's hospital admission and following hospital admission combined.",[13,14,15,16,17,18,19,20],[27,33,39,43,49,55,61,67],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Ampicillin for Injection","Ampicillin is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia.",[9,22],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Ceftriaxone for Injection","Ceftriaxone is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia.",[9,22],[38],"Rocephin",{"type":28,"name":40,"description":41,"armGroupLabels":42,"otherNames":32},"Amoxicillin","Amoxicillin is an oral antibiotic commonly used in the treatment of children hospitalized with community-acquired pneumonia to complete the antibiotic course after discharge.",[9,22],{"type":28,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Ampicillin \u002F Sulbactam Injection","Ampicillin\u002FSulbactam is an intravenous antibiotic commonly used in the initial treatment of children hospitalized with community-acquired pneumonia.",[9,22],[48],"Unasyn",{"type":28,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Amoxicillin-clavulanate","Amoxicillin-clavulanate is an oral antibiotic commonly used in the treatment of children hospitalized with community-acquired pneumonia to complete the antibiotic course after discharge.",[9,22],[54],"Augmentin",{"type":28,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"Clindamycin","Clindamycin is an antibiotic that can be given intravenously or orally that is sometimes used in the treatment of children hospitalized or discharged with community-acquired pneumonia.",[9,22],[60],"Cleocin",{"type":28,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"Cefprozil","Cefprozil is an oral antibiotic sometimes used in the treatment of children hospitalized with community-acquired pneumonia to complete the antibiotic course after discharge.",[9,22],[66],"Cefzil",{"type":28,"name":68,"description":69,"armGroupLabels":70,"otherNames":71},"Levofloxacin","Levofloxacin is an antibiotic that can be given intravenously or orally that is sometimes used in the treatment of children hospitalized or discharged with community-acquired pneumonia.",[9,22],[72],"Levaquin",[74],{"name":75,"affiliation":5,"role":76},"Michelle Mitchell","PRINCIPAL_INVESTIGATOR",[78,83],{"name":79,"role":80,"phone":81,"phoneExt":32,"email":82},"Michelle Mitchell, MD","CONTACT","414-337-7070","mimitchell@mcw.edu",{"name":84,"role":80,"phone":81,"phoneExt":32,"email":85},"Khaled AL zubaidi, MD","kalzubaidi@mcw.edu",[87],{"facility":88,"status":89,"city":90,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":101},"Childrens Wisconsin","RECRUITING","Milwaukee","Wisconsin","53226","United States","US",{"type":96,"coordinates":97},"Point",[98,99],-87.90647,43.0389,{"lat":99,"lon":98},[102,104,105],{"name":79,"role":80,"phone":103,"phoneExt":32,"email":82},"4143377070",{"name":79,"role":76,"phone":32,"phoneExt":32,"email":32},{"name":106,"role":107,"phone":32,"phoneExt":32,"email":32},"khaled al zubaidi, MD","SUB_INVESTIGATOR",{"type":76,"investigatorFullName":75,"investigatorTitle":109,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Associate Professor of Pediatric Infectious Diseases","100554052","phase-4-short-versus-standard-of-care-antibiotic-duration-for-children-hospitalized-for-cap-100554052",false,"NCT06494072","Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP","Short Versus Standard of Care Antibiotic Duration for Hospitalized Children With Uncomplicated Community-acquired Pneumonia: a Non-inferiority, Randomized Controlled Trial.","Inclusion Criteria (ALL of the following must be met):\n\n1. Children aged 3 months to \\\u003C18 years old\n2. Hospitalized in either the acute care or the pediatric intensive care units\n3. Clinically diagnosed with uncomplicated bacterial community acquired pneumonia (as determined by the treating physician)\n4. Radiological findings suggestive of pneumonia (such as consolidation, lobar or interstitial infiltrates)\n5. Achieved clinical stability within 72 hours from the first antibiotic dose (clinical stability includes being off supplemental oxygen\u002Fventilatory support and temperature remaining \\\u003C 38 Celsius).\n\nExclusion Criteria (presence of ANY of the following will exclude a potential participant):\n\n1. Hemodynamic instability at any point during hospitalization that required inotropic support\n2. Requirement of respiratory support \\> 72 hours\n3. Presence of a parapneumonic effusion \\>10 mm on decubitus x-ray or greater than ¼ of hemithorax opacified on chest imaging\n4. Need for chest tube placement\n5. Extrapulmonary involvement (ie: another infection located outside of the lungs) except for otitis media if the planned treatment is ≤ 5 days\n6. Pneumonia caused by known staphylococcus aureus identified from culture (blood, bronchoalveolar aspirate, tracheal aspirate, or pleural fluid)\n7. Antibiotic course started \\>72 hours after admission\n8. Antibiotics used for \\> 24 hours within the 2 weeks prior to admission\n9. Chronic respiratory illness other than asthma or reactive airway disease\n10. Immunocompromised patient (primary or secondary)\n11. Primary physician refusal\n12. Parent refusal\n13. Non-English speakers\n14. Pregnant or lactating female\n15. Participant will become ≥ 18 years old at or before the time of day 14 follow up\n16. Inability to adhere to follow up","ALL","3 Months","18 Years",{"count":121,"type":122},236,"ESTIMATED","INTERVENTIONAL",[125],"PHASE4","The goal of this open label, randomized, non-inferiority clinical trial is to compare the treatment success of a 5 day antibiotic course versus a standard antibiotic course (usually 7-14 days of antibiotics) in hospitalized children aged 3 months to 18 years, with uncomplicated community acquired pneumonia.\n\nThe main questions it aims to answer are:\n\n* Does a 5 day course work as well as standard (longer) courses of antibiotics for treating community acquired pneumonia in children?\n* Does a 5 day course cause less antibiotic side effects compared to a standard (longer) course of antibiotics in children with community acquired pneumonia?\n\nParticipants will\n\n* be randomly assigned to either receive 5 total days or a total duration decided by the treating physician\n* receive a brief follow up questionnaire regarding clinical symptoms, follow up care\u002Fantibiotics, and side effects via phone or email at days 5 and 14 from the start of antibiotics\n\nResearchers will compare the experimental group (receiving 5 days duration) with the control group (standard duration) to see if 5 days is as successful as a standard duration.",[128],"Community Acquired Pneumonia in Children",[130,131,132,133,134],"inpatient","pediatric","hospitalized","community acquired pneumonia.","antibiotic duration","2026-02-26",{"date":137,"type":138},"2026-03-02","ACTUAL",{"date":140,"type":138},"2024-08-22",{"date":142,"type":122},"2028-05",{"name":5,"class":6},1]