Azithromycin in the Management of Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis
NCT ID: NCT05842681
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2023-06-01
2026-04-30
Brief Summary
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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.
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Detailed Description
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SCALE-IPF (Severity Classification and Lung Evaluation for Prognosis in IPF; locked April 2023, archived November 2025, digital object identifier \[DOI\] 10.5281/zenodo.17575973) served as the prespecified baseline severity classification and stratification framework. IPIM (Idiopathic Pulmonary Fibrosis Phenotypes Identification Model; locked April 2023, archived November 2025, DOI 10.5281/zenodo.17576160) was applied as a predefined phenotypic framework integrating clinical, functional, and radiological domains.
Severity and phenotypic frameworks were used exclusively to define eligibility and baseline characterization. They did not influence randomization procedures, treatment allocation, trial conduct, or study endpoints, and were applied to support reproducibility and structured interpretation of therapeutic effects across severity and phenotypic spectra.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional therapy group
Patients will receive conventional treatment for acute exacerbation of IPF, including pulse corticosteroid therapy and supportive treatment, and oxygen therapy.
Methylprednisolone
methylprednisolone 500 mg single intra-venous daily dose for three days
Add-on Azithromycin
Patients will receive conventional therapy and Add-on Azithromycin 500 mg single daily dose for five days
Azithromycin
A single daily oral dose of Azithromycin tablet 500 mg for five days
Methylprednisolone
methylprednisolone 500 mg single intra-venous daily dose for three days
Interventions
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Azithromycin
A single daily oral dose of Azithromycin tablet 500 mg for five days
Methylprednisolone
methylprednisolone 500 mg single intra-venous daily dose for three days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participation within the Assiut University IPF Research Program (2022-2026).
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Ahmad Shaddad
Lecturer of pulmonary medicine Assuit university
Principal Investigators
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ahmad M shaddad
Role: PRINCIPAL_INVESTIGATOR
Assiut university-Faculty of Medicine
Locations
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Assiut university-Faculty of Medicine
Asyut, , Egypt
Faculty of Medicine Assuit University
Asyut, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2516771716
Identifier Type: -
Identifier Source: org_study_id
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