Azithromycin in the Management of Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis

NCT05842681 | Recruiting DMC

• 1 other identifier: 2516771716
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Hospital stay

  the main aime of the study to assess the hospital stay expressed in days in the Add-on Azithromycin 500 mg single oral daily dose in comparison to the conventional therapy group only

  5-10 Days ( Days of Hospital admission until improvement and discharge)

Secondary Outcomes (4)

• Change in clinical outcome measures stratified by SCALE-IPF severity

  From randomization (Day 1) to Month 3 post-enrollment.

• Association between SCALE-IPF severity and one-year mortality

  Baseline to 12 months post-randomization.

• Correlation between azithromycin response and IPIM phenotypic clusters

  Baseline to 12 months post-randomization.

• Event-free survival across SCALE-IPF strata

  Baseline to 12 months post-randomization.

Other Outcomes (1)

• Analytical validation of SCALE-IPF and IPIM within the randomized AE-IPF cohort

  Baseline to 12 months post-randomization.

Study Arms (2)

Conventional therapy group

ACTIVE COMPARATOR

Patients will receive conventional treatment for acute exacerbation of IPF, including pulse corticosteroid therapy and supportive treatment, and oxygen therapy.

Drug: Methylprednisolone

Add-on Azithromycin

ACTIVE COMPARATOR

Patients will receive conventional therapy and Add-on Azithromycin 500 mg single daily dose for five days

Drug: Azithromycin; Drug: Methylprednisolone

Interventions

Azithromycin DRUG

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

Also known as: azithromycin 500 mg oral tablet

Add-on Azithromycin

Methylprednisolone DRUG

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

Also known as: methylprednisolone 500 mg

Add-on Azithromycin; Conventional therapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (2)

Assiut university-Faculty of Medicine

Asyut, 71515, Egypt

RECRUITING

Faculty of Medicine Assuit University

Asyut, Egypt

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Azithromycin; Methylprednisolone

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• ahmad M shaddad

  Assiut university-Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ahmad M shaddad, MD

CONTACT

01111171930; shaddad_ahmad@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of pulmonary medicine Assuit university

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: April 23, 2023
• First Posted: May 6, 2023
• Study Start: June 1, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)