RecruitingNot ApplicableNCT05842681

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


Sponsor

Assiut University

Enrollment

30 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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 IPIM (Idiopathic Pulmonary Fibrosis Phenotypes Identification Model; locked April 2023). Both 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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria2

  • 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).

Exclusion Criteria5

  • 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.

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Interventions

DRUGAzithromycin

A single daily oral dose of Azithromycin tablet 500 mg for five days

DRUGMethylprednisolone

methylprednisolone 500 mg single intra-venous daily dose for three days


Locations(2)

Assiut university-Faculty of Medicine

Asyut, Egypt

Faculty of Medicine Assuit University

Asyut, Egypt

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NCT05842681


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