Azithromycin for Critical Asthma - Pediatrics

Launched by JOHNS HOPKINS ALL CHILDREN'S HOSPITAL · Jan 16, 2024

Nctid: NCT06223828

Payload: {"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000001249", "term"=>"Asthma"}, {"id"=>"D000016638", "term"=>"Critical Illness"}], "ancestors"=>[{"id"=>"D000001982", "term"=>"Bronchial Diseases"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D000008173", "term"=>"Lung Diseases, Obstructive"}, {"id"=>"D000008171", "term"=>"Lung Diseases"}, {"id"=>"D000012130", "term"=>"Respiratory Hypersensitivity"}, {"id"=>"D000006969", "term"=>"Hypersensitivity, Immediate"}, {"id"=>"D000006967", "term"=>"Hypersensitivity"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}, {"id"=>"D000020969", "term"=>"Disease Attributes"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M4556", "name"=>"Asthma", "asFound"=>"Asthma", "relevance"=>"HIGH"}, {"id"=>"M19010", "name"=>"Critical Illness", "asFound"=>"Critical Illness", "relevance"=>"HIGH"}, {"id"=>"M5258", "name"=>"Bronchial Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M11170", "name"=>"Lung Diseases, Obstructive", "relevance"=>"LOW"}, {"id"=>"M14967", "name"=>"Respiratory Hypersensitivity", "relevance"=>"LOW"}, {"id"=>"M10018", "name"=>"Hypersensitivity", "relevance"=>"LOW"}, {"id"=>"M10020", "name"=>"Hypersensitivity, Immediate", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000017963", "term"=>"Azithromycin"}], "ancestors"=>[{"id"=>"D000000900", "term"=>"Anti-Bacterial Agents"}, {"id"=>"D000000890", "term"=>"Anti-Infective Agents"}], "browseLeaves"=>[{"id"=>"M20132", "name"=>"Azithromycin", "asFound"=>"Preoperative", "relevance"=>"HIGH"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2", "PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NON_RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"Children will be enrolled into either a single interventional arm or a parallel standard care arm."}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>100}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-04-02", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-04", "completionDateStruct"=>{"date"=>"2025-06-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-04-18", "studyFirstSubmitDate"=>"2024-01-16", "studyFirstSubmitQcDate"=>"2024-01-16", "lastUpdatePostDateStruct"=>{"date"=>"2024-04-19", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-06-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Plasma Periostin Levels and Degree of Change (e.g., Slope) - Primary Physiologic Efficacy Endpoint", "timeFrame"=>"24 hours, 48 hours, and 72-hours following enrollment", "description"=>"ng/dL"}, {"measure"=>"Drug-related adverse event rate (Primary Safety Endpoint)", "timeFrame"=>"During hospitalization, approximately 3 days", "description"=>"cumulative incidence rate"}], "secondaryOutcomes"=>[{"measure"=>"Length of Stay (Secondary Clinical Efficacy Endpoint)", "timeFrame"=>"During hospitalization, approximately 3 days", "description"=>"Measured in Days, from Hospitalization in ICU through Discharge from ICU"}, {"measure"=>"Duration of continuous albuterol (Secondary Clinical Efficacy Endpoint)", "timeFrame"=>"During hospitalization, approximately 3 days", "description"=>"Measured in Hours from ICU hospitalization through discharge"}, {"measure"=>"Composite use of adjunct asthma treatments (Secondary Clinical Efficacy Endpoint)", "timeFrame"=>"During hospitalization, approximately 3 days", "description"=>"Cumulative Frequency of Exposure, from ICU Hospitalization through ICU discharge"}, {"measure"=>"Transcutaneous carbon dioxide levels (Secondary physiologic efficacy Endpoint)", "timeFrame"=>"Enrollment, Day 1, Day 2, Day 3, at ICU Discharge", "description"=>"Measured in mmHg of Carbon Dioxide, peak values measured daily at each study visit"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Pediatric Asthma", "Critical Illness"]}, "descriptionModule"=>{"briefSummary"=>"The CR-AZI Study will assess the immunomodulatory effects of Azithromycin for pediatric Critical Asthma.", "detailedDescription"=>"Azithromycin (AZI), a macrolide antibiotic, has been applied for adult and pediatric respiratory pathology to alter immune system response.1 For pediatric critical asthma (CA), a term used to describe a critically ill child hospitalized with an asthma exacerbation requiring an intensive care unit (PICU) hospitalization, the investigator's prior research has revealed 1 in 10 will receive AZI.2 Yet, the application of AZI in this setting is poorly studied nor is clear if, and to what degree AZI alters the immune response in conjunction with systemic corticosteroids traditionally applied in CA.\n\nIn this proposal, the investigators aim to characterize a respiratory epithelial inflammatory biomarker, periostin, among children with CA with and without exposure to AZI. The investigators hypothesize children receiving AZI will have lower periostin levels. As a secondary analysis, the investigators will describe the rates of adverse events related to AZI (previously not done) and explore differences in clinical and physiologic CA efficacy markers."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"17 years", "minimumAge"=>"3 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion criteria\n\n* Age 3-17 years\n* Admission to the PICU\n* Primary diagnosis of critical asthma\n* Prescription for continuous inhaled beta-agonist therapy and/or intravenous (IV) beta-agonist therapy\n* Prescription for intravenous systemic corticosteroids\n\nExclusion criteria\n\n* Critical Congenital Heart Disease Unrepaired\n* Tracheostomy Dependence at Admission\n* Ongoing Exposure to Azithromycin or Macrolide Antibiotics for any indication\n* Past Medical History of Prolonged QT Syndrome or Arrhythmias\n* Concomitant respiratory pathology including Acute Chest Syndrome, Interstitial Lung Disease, Cystic Fibrosis, and pulmonary hypertension"}, "identificationModule"=>{"nctId"=>"NCT06223828", "acronym"=>"CR-AZI Kids", "briefTitle"=>"Azithromycin for Critical Asthma - Pediatrics", "organization"=>{"class"=>"OTHER", "fullName"=>"Johns Hopkins All Children's Hospital"}, "officialTitle"=>"Azithromycin as Immunomodulation Among Children Hospitalized for Critical Asthma: A Prospective, Open-Label, Non-Randomized, Interventional Study With Parallel Biospecimen Banking", "orgStudyIdInfo"=>{"id"=>"CR-AZI"}, "secondaryIdInfos"=>[{"id"=>"IRB00410054", "type"=>"OTHER", "domain"=>"Johns Hopkins University"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Azithromycin Intervention", "description"=>"Participants in this arm will receive Azithromycin 10mg/kg/dose (max dose 500mg) once daily for 3 days.", "interventionNames"=>["Drug: Azithromycin"]}, {"type"=>"NO_INTERVENTION", "label"=>"Standard Care", "description"=>"Participants will receive standard care without Azithromycin."}], "interventions"=>[{"name"=>"Azithromycin", "type"=>"DRUG", "otherNames"=>["Zithromax"], "description"=>"10mg/kg/dose (max dose 500mg) once daily for 3 days", "armGroupLabels"=>["Azithromycin Intervention"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"33701", "city"=>"Saint Petersburg", "state"=>"Florida", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Anthony A Sochet, MD", "role"=>"CONTACT", "email"=>"sochet@jhmi.edu", "phone"=>"727-767-2912"}], "facility"=>"Johns Hopkins All Children's Hospital", "geoPoint"=>{"lat"=>27.77086, "lon"=>-82.67927}}], "centralContacts"=>[{"name"=>"Anthony A Sochet, MD", "role"=>"CONTACT", "email"=>"Sochet@jhmi.edu", "phone"=>"727-487-3711"}, {"name"=>"Alexa R Roberts, MD", "role"=>"CONTACT", "email"=>"arober77@jhmi.edu", "phone"=>"602-526-4397"}], "overallOfficials"=>[{"name"=>"Anthony A Sochet, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Johns Hopkins All Children's Hospital"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"No plan to share with other researchers."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Johns Hopkins All Children's Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}