[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504008":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":49,"centralContacts":54,"locations":61,"responsibleParty":83,"collaborators":59,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":59,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":59,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":59,"overallStatus":63,"whyStopped":59,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Assiut University","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional therapy group","ACTIVE_COMPARATOR","Patients will receive conventional treatment for acute exacerbation of IPF, including pulse corticosteroid therapy and supportive treatment, and oxygen therapy.",[13],"Drug: Methylprednisolone",{"label":15,"type":16,"description":17,"interventionNames":18},"Add-on Azithromycin","EXPERIMENTAL","Patients will receive conventional therapy and Add-on Azithromycin 500 mg single daily dose for five days then Patients will receive conventional treatment and early adjunctive azithromycin according to the study treatment protocol. Azithromycin will be administered as a 500 mg oral dose three times weekly during longitudinal follow-up according to tolerability and standard clinical safety monitoring. This arm represents the early inflammatory intervention strategy targeting inflammatory disease behavior in idiopathic pulmonary fibrosis.",[19,13],"Drug: Azithromycin",{"label":21,"type":10,"description":22,"interventionNames":23},"Pirfenidone Therapy","Pirfenidone will be administered according to the standard full-dose protocol as 801 mg orally three times daily, corresponding to a total daily dose of 2403 mg\u002Fday. This regimen is equivalent to nine 267 mg tablets\u002Fcapsules per day, given as three tablets\u002Fcapsules three times daily, according to tolerability and standard safety monitoring.",[24],"Drug: Pirfenidone",{"label":26,"type":16,"description":27,"interventionNames":28},"Pirfenidone Plus Azithromycin Therapy","Patients will receive pirfenidone therapy according to the standard full-dose protocol: 801 mg orally three times daily, equivalent to a total daily dose of 2403 mg\u002Fday, administered as three 267 mg tablets\u002Fcapsules three times daily, combined with adjunctive azithromycin administered as a 500 mg oral dose three times weekly according to the study treatment protocol and standard safety monitoring.",[19,24],[30,37,43],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Azithromycin","A single daily oral dose of azithromycin 500 mg for five days during acute exacerbation, followed by azithromycin 500 mg orally three times weekly as maintenance therapy during longitudinal follow-up according to tolerability and standard clinical safety monitoring.",[15,26],[36],"azithromycin 500 mg oral tablet",{"type":31,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Methylprednisolone","methylprednisolone 500 mg single intra-venous daily dose for three days",[15,9],[42],"methylprednisolone 500 mg",{"type":31,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Pirfenidone","Pirfenidone will be administered according to the standard full-dose protocol as 801 mg orally three times daily, equivalent to a total daily dose of 2403 mg\u002Fday, administered as three 267 mg tablets\u002Fcapsules three times daily according to tolerability and standard clinical safety monitoring.",[26,21],[48],"Pirfenidone 267 mg oral tablet\u002Fcapsule",[50],{"name":51,"affiliation":52,"role":53},"ahmad M shaddad","Assiut university-Faculty of Medicine","PRINCIPAL_INVESTIGATOR",[55],{"name":56,"role":57,"phone":58,"phoneExt":59,"email":60},"ahmad M shaddad, MD","CONTACT","01111171930",null,"shaddad_ahmad@yahoo.com",[62,77],{"facility":52,"status":63,"city":64,"state":59,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"RECRUITING","Asyut","71515","Egypt","EG",{"type":69,"coordinates":70},"Point",[71,72],31.18368,27.18096,{"lat":72,"lon":71},[75],{"name":76,"role":57,"phone":58,"phoneExt":59,"email":60},"ahmad shaddad, MD",{"facility":78,"status":79,"city":64,"state":59,"zip":59,"country":66,"countryCode":67,"cosmosGeoPoint":80,"geoPoint":82,"contacts":59},"Faculty of Medicine Assuit University","ACTIVE_NOT_RECRUITING",{"type":69,"coordinates":81},[71,72],{"lat":72,"lon":71},{"type":53,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":59,"oldOrganization":59},"Ahmad Shaddad","Lecturer of pulmonary medicine Assuit university","100504008","azithromycin-in-the-management-of-patients-with-acute-exacerbation-of-idiopathic-pulmonary-fibrosis-100504008",false,"NCT05842681","Azithromycin in the Management of Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis","Role of Add-on Azithromycin in the Management of Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis","Inclusion Criteria:\n\n* Baseline disease severity classified as mild or early-moderate according to the SCALE-IPF (locked April 2023) threshold ≤ 13 points.\n* Participation within the Assiut University IPF Research Program (2022-2026).\n* Additional longitudinal therapeutic platform arms involving pirfenidone with or without azithromycin may include clinically stable idiopathic pulmonary fibrosis patients according to protocol-amended eligibility criteria approved in September 2025.\n\nExclusion Criteria:\n\n* Age: less than 18 years.\n* Patients with any severity other than mild or early-moderate acute exacerbation of IPF according to SCALE-IPF (locked April 2023).\n* Patients with multislice computed tomography with a radiological pattern rather than usual interstitial pneumonitis (UIP).\n* Unstable patients need mechanical ventilation or Respiratory Intensive Care Unit admission.\n* Patients with end-organ failure.\n* Patients with known hypersensitivity or contraindication to pirfenidone or azithromycin, significant hepatic impairment, severe drug intolerance, or other contraindications to study medications according to standard clinical judgment.","ALL","18 Years","80 Years",{"count":97,"type":98},1000,"ESTIMATED","INTERVENTIONAL",[101],"NA","This randomized controlled trial evaluates the therapeutic role of azithromycin in acute exacerbations of idiopathic pulmonary fibrosis (AE-IPF). Baseline severity classification and stratification were performed using the SCALE-IPF framework (Severity Classification and Lung Evaluation for Prognosis in IPF; locked April 2023) to ensure balanced disease severity across randomized arms. End-of-study analyses included descriptive and stratified phenotyping using the Idiopathic Pulmonary Fibrosis Phenotypes Identification Model (IPIM); locked April 2023).\n\nFollowing a protocol amendment approved in September 2025, the study expanded into a multi-arm therapeutic platform evaluating both azithromycin timing strategies and combination antifibrotic-immunomodulatory therapy in idiopathic pulmonary fibrosis. Additional treatment arms involving pirfenidone with or without azithromycin were incorporated without altering the original randomized comparisons or baseline study framework.\n\nBoth frameworks were developed within the Assiut University IPF Research Program (2022-2026), a coordinated institutional effort investigating clinical, prognostic, and therapeutic dimensions of IPF. Neither framework altered randomization procedures, treatment allocation, or study endpoints; they were applied to improve standardization, reproducibility, and interpretability of results.",[104],"Idiopathic Pulmonary Fibrosis","2026-05-11",{"date":107,"type":108},"2026-05-13","ACTUAL",{"date":110,"type":108},"2023-06-01",{"date":112,"type":98},"2027-02-28",{"name":5,"class":6},2]