Azithromycin for acute exacerbations of idiopathic pulmonary fibrosis

Role of Add-on Azithromycin in the Management of Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Assiut University (Academic / other)
• Locations: 2 sites (Asyut and 1 other locations)
• Trial ID: NCT05842681 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

Why it matters

Potential benefit: If effective, adding azithromycin could improve recovery or reduce complications during acute exacerbations of IPF.

How similar studies have performed: 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.

Eligibility 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 this trial is running

Asyut and 1 other locations

• 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

Conditions Idiopathic Pulmonary Fibrosis