Azithromycin for acute exacerbations of idiopathic pulmonary fibrosis
Official title: Role of Add-on Azithromycin in the Management of Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Run by Assiut University · NCT05842681 · Data updated 2026-11-12
This study will test whether adding azithromycin to standard care helps people with mild to early-moderate acute exacerbations of idiopathic pulmonary fibrosis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Assiut University Academic / other |
| Locations | 2 sites (Asyut and 1 other locations) |
| Status | Recruiting |
| Started | June 1, 2023 |
| Main results expected | January 1, 2027 |
| Study ends | February 28, 2027 |
| Registry record updated | May 13, 2026 |
| Trial ID | NCT05842681 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with IPF experiencing a mild or early‑moderate acute exacerbation who meet the SCALE‑IPF threshold (≤13 points) and can receive care at Assiut University are the intended candidates.
✕Probably not a fit
Patients with more severe exacerbations, non‑UIP radiology, need for mechanical ventilation or ICU care, end‑organ failure, or known contraindications to the study drugs are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, open-label controlled trial at Assiut University that initially randomized patients with mild or early‑moderate acute exacerbations of IPF to receive standard therapy with or without azithromycin. Baseline severity was stratified using the SCALE‑IPF framework and end‑of‑study descriptive and stratified phenotyping used the IPIM model to characterize responses. The original target enrollment was about 130 participants, and a protocol amendment in September 2025 expanded the protocol into a single‑center multi‑arm therapeutic platform adding pirfenidone ± azithromycin and other antifibrotic‑immunomodulatory combinations. The stratification and phenotyping frameworks were applied for eligibility and structured interpretation and did not alter randomization or treatment allocation.
Why it matters
Potential benefit: If effective, adding azithromycin could improve recovery or reduce complications during acute exacerbations of IPF.
How similar studies have gone: Macrolides like azithromycin have shown possible benefit in observational studies and in other acute lung conditions, but randomized evidence specific to AE‑IPF is limited and the platform combination approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Assiut university-Faculty of Medicine
Asyut, Egypt Recruiting -
Faculty of Medicine Assuit University
Asyut, Egypt Active not recruiting
Study contacts
- Principal investigator: ahmad M shaddad — Assiut university-Faculty of Medicine
- Study coordinator: ahmad M shaddad, MD
- Email: shaddad_ahmad@yahoo.com
- Phone: 01111171930
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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New IPF drug ORJ-001 tested in adults with IPF
A phase 2 study tests ORJ-001 versus placebo in adults with idiopathic pulmonary fibrosis to see if it is tolerated and whether it helps lung function.
-
Nalbuphine ER for IPF-related chronic cough
This study tests whether extended-release nalbuphine tablets can reduce chronic cough in people with idiopathic pulmonary fibrosis.
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Inspiratory Flow Rate Capability in Pulmonary Fibrosis Patients
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Photon-counting CT vs standard HRCT to help diagnose IPF and other ILDs
This study tests whether photon-counting CT can improve identifying IPF and other ILDs compared with standard HRCT for patients discussed in multidisciplinary teams.
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Rentosertib by mouth for people with idiopathic pulmonary fibrosis
This is a randomized, placebo-controlled test to see if Rentosertib helps adults with idiopathic pulmonary fibrosis when taken as a pill.
-
Inhaled nintedanib powder for IPF in adults
This study tests whether an inhaled form of nintedanib can safely help adults with idiopathic pulmonary fibrosis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.