Actively Recruiting
Role of Add-on Azithromycin in the Management of Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Led by Assiut University · Updated on 2026-05-13
1000
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the therapeutic role of azithromycin in treating acute exacerbations of idiopathic pulmonary fibrosis (AE-IPF). The trial is part of the Assiut University IPF Research Program and uses the SCALE-IPF framework to classify disease severity and the IPIM model for phenotyping patients. In September 2025, the study expanded into a multi-arm platform to also assess combination antifibrotic and immunomodulatory therapies, including pirfenidone with or without azithromycin, without changing the original study design or endpoints. Participants receive conventional treatment for AE-IPF, including pulse corticosteroids and oxygen therapy. Four study groups exist: one receiving conventional therapy alone; another receiving conventional therapy plus azithromycin; a third receiving standard-dose pirfenidone; and a fourth receiving pirfenidone combined with azithromycin. Azithromycin is given initially as a 500 mg daily dose for five days, then three times weekly during follow-up. Pirfenidone is administered orally at 801 mg three times daily according to standard dosing and safety monitoring. During the study, participants are monitored for hospital stay duration, clinical outcomes stratified by disease severity, one-year mortality, and event-free survival over 12 months. Researchers use clinical, functional, and radiological assessments based on the SCALE-IPF and IPIM frameworks to evaluate treatment effects. Safety monitoring and standard clinical evaluations occur throughout the follow-up period, which includes up to one year post-randomization.
CONDITIONS
Brief Title
Azithromycin in the Management of Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Baseline disease severity classified as mild or early-moderate according to the SCALE-IPF threshold (13 points or less).
- Participation within the Assiut University IPF Research Program (2022-2026).
- Clinically stable idiopathic pulmonary fibrosis patients may be included in additional treatment arms involving pirfenidone with or without azithromycin, as per protocol amendment approved in September 2025.
You will not qualify if you...
- Age less than 18 years.
- Acute exacerbation severity other than mild or early-moderate according to SCALE-IPF.
- Radiological pattern other than usual interstitial pneumonitis on multislice computed tomography.
- Unstable patients requiring mechanical ventilation or respiratory intensive care.
- Presence of end-organ failure.
- Known hypersensitivity or contraindication to pirfenidone or azithromycin.
- Significant liver impairment or severe drug intolerance.
- Other contraindications to study medications as judged clinically.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 to 10 days (hospital stay until improvement and discharge)
Participants receive assigned therapy for acute exacerbation of idiopathic pulmonary fibrosis, including conventional treatment with pulse corticosteroid therapy and oxygen, with or without azithromycin and/or pirfenidone according to randomization group.
Daily treatment visits during hospital stay
Duration - Up to 12 months
Participants continue maintenance therapy with azithromycin and/or pirfenidone as applicable, with ongoing safety monitoring and evaluation up to 12 months post-randomization.
Regular visits for clinical outcome assessments and safety monitoring during follow-up
Trial Site Locations
Total: 2 locations
1
Assiut university-Faculty of Medicine
Asyut, Egypt, 71515
Actively Recruiting
2
Faculty of Medicine Assuit University
Asyut, Egypt
Active, Not Recruiting
Research Team
A
ahmad M shaddad, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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