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

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Azithromycin
Methylprednisolone
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients will be eligible for enrolment if diagnosed with Mild exacerbation of IPF and admitted to the Chest Department of Assiut University, requiring ventilator support without invasive mechanical ventilation. Exclusion Criteria: Age: less than 18 years. Patients with any severity other than mild Acute exacerbation of IPF Patients with MSCT with a radiological pattern rather than UIP Unstable patients need mechanical ventilation or RICU admission Patients with end-organ failure.

Sites / Locations

  • Assiut university-Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Conventional therapy group

Add-on Azithromycin

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 23, 2023
Last Updated
May 2, 2023
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05842681
Brief Title
Azithromycin in the Management of Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Official Title
Role of Add-on Azithromycin in the Management of Patients With Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study will assess the role of using azithromycin in managing acute exacerbation of Idiopathic pulmonary fibrosis
Detailed Description
Idiopathic pulmonary fibrosis (IPF) is a progressive and irreversible fibrotic lung disease with a variable disease course. Most patients with IPF have a relatively slow clinical course, but up to 15% of patients experience an acute exacerbation of IPF (AE-IPF) each year, defined as an acute worsening or development of dyspnea and new bilateral ground-glass abnormality and/or consolidation on high-resolution computed tomography (HRCT). A recent epidemiologic survey of Japanese patients with IPF showed that the most common cause of death was AE-IPF. The outcome of AE-IPF is very poor. The reported 1-month mortality rate is approximately 60%, and the reported in-hospital mortality rate ranges from 50 to 60%. AE-IPF lacks an effective pharmaceutical treatment. Current guidelines recommend that most patients with AE-IPF should be treated with corticosteroids, but no controlled trials support this recommendation. The International Working Group recently proposed a revised definition and diagnostic criteria for AE-IPF. Previous diagnostic criteria. recommended the strict exclusion of other causes of acute worsening of respiratory disease, but new criteria have permitted physicians to include patients with triggered AE in addition to idiopathic AE-IPF. In studies of the treatment and outcomes of AE-IPF, almost all patients received empirical antibiotics in addition to corticosteroids despite the lack of controlled trials showing the benefit of empirical treatment. Azithromycin is a macrolide with immunomodulatory properties and anti-inflammatory effects. Previous reports have described the effectiveness of macrolides in patients with serious conditions, such as severe pneumonia and acute lung injury. Until 2011, erythromycin was the only macrolide that could be used by intravenous injection in Japan. Still, erythromycin has many side effects and drug interactions, so we did not routinely use intravenous erythromycin in daily clinical practice. In cases of suspected AE-IPF, we used quinolone-based antibiotics. Intravenous azithromycin has been approved for clinical use since September 2011 in Japan. Azithromycin is safer and easier to use than erythromycin, and since the publication of Walkey's report, we routinely use azithromycin for patients with acute respiratory failure since July 2012. We previously reported that intravenous azithromycin was associated with improved outcomes in patients with AE of chronic fibrosing interstitial pneumonia. However, that report had two major limitations: the very small number of patients treated with azithromycin and the inclusion of patients with nonspecific interstitial pneumonia and chronic hypersensitivity pneumonia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional therapy group
Arm Type
Active Comparator
Arm Description
Patients will receive conventional treatment for acute exacerbation of IPF, including pulse corticosteroid therapy and supportive treatment, and oxygen therapy.
Arm Title
Add-on Azithromycin
Arm Type
Active Comparator
Arm Description
Patients will receive conventional therapy and Add-on Azithromycin 500 mg single daily dose for five days
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Other Intervention Name(s)
azithromycin 500 mg oral tablet
Intervention Description
A single daily oral dose of Azithromycin tablet 500 mg for five days
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Other Intervention Name(s)
methylprednisolone 500 mg
Intervention Description
methylprednisolone 500 mg single intra-venous daily dose for three days
Primary Outcome Measure Information:
Title
Hospital stay
Description
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
Time Frame
5-10 Days ( Days of Hospital admission until improvement and discharge)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients will be eligible for enrolment if diagnosed with Mild exacerbation of IPF and admitted to the Chest Department of Assiut University, requiring ventilator support without invasive mechanical ventilation. Exclusion Criteria: Age: less than 18 years. Patients with any severity other than mild Acute exacerbation of IPF Patients with MSCT with a radiological pattern rather than UIP Unstable patients need mechanical ventilation or RICU admission Patients with end-organ failure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ahmad M shaddad, MD
Phone
01111171930
Email
shaddad_ahmad@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ahmad M shaddad
Organizational Affiliation
Assiut university-Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university-Faculty of Medicine
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ahmad shaddad, MD
Phone
01111171930
Email
shaddad_ahmad@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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