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Azithromycin in the Management of Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis

RecruitingNAAges 18 Years - 80 YearsAllAssiut University
NCT05842681 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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). Following 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 incorpo

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📋 Eligibility rules (as published)
Inclusion Criteria: * Baseline disease severity classified as mild or early-moderate according to the SCALE-IPF (locked April 2023) threshold ≤ 13 points. * Participation within the Assiut University IPF Research Program (2022-2026). * 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. Exclusion Criteria: * Age: less than 18 years. * Patients with any severity other than mild or early-moderate acute exacerbation of IPF according to SCALE-IPF (locked April 2023). * Patients with multislice computed tomography with a radiological pattern rather than usual interstitial pneumonitis (UIP). * Unstable patients need mechanical ventilation or Respiratory Intensive Care Unit admission. * Patients with end-organ failure. * 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.
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What it tests

  • Azithromycin
  • Methylprednisolone
  • Pirfenidone
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Where

2 sites
Assiut university-Faculty of Medicine
Asyut, Egypt
Faculty of Medicine Assuit University
Asyut, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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