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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This randomized controlled trial evaluates the therapeutic role of azithromycin in acute exacerbations of idiopathic pulmonary fibrosis (AE-IPF). Baseline classification and randomization were guided by the SCALE-IPF framework (Severity Classification and Lung Evaluation for Prognosis in IPF; locked April 2023) to ensure balanced disease severity across arms. End-of-study analyses included descriptive phenotyping using the IPIM (Idiopathic Pulmonary Fibrosis Phenotypes Identification Model; locked August 2024). 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 treatment allocation or endpoints; they were applied to improve standardization, reproducibility, and interpretability of results.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Egypt
Assiut university-Faculty of Medicine
RECRUITING
Asyut
Faculty of Medicine Assuit University
ACTIVE_NOT_RECRUITING
Asyut
Contact Information
Primary
ahmad M shaddad, MD
shaddad_ahmad@yahoo.com
01111171930
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 30
Treatments
Active_comparator: Conventional therapy group
Patients will receive conventional treatment for acute exacerbation of IPF, including pulse corticosteroid therapy and supportive treatment, and oxygen therapy.
Active_comparator: Add-on Azithromycin
Patients will receive conventional therapy and Add-on Azithromycin 500 mg single daily dose for five days
Sponsors
Leads: Assiut University

This content was sourced from clinicaltrials.gov