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

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05842681

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will assess the role of using azithromycin in managing acute exacerbation of Idiopathic pulmonary fibrosis

Condition or Disease	Intervention/Treatment	Phase
Idiopathic Pulmonary Fibrosis	Drug: Azithromycin Drug: Methylprednisolone	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trialRandomized controlled trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Methylprednisolone methylprednisolone 500 mg single intra-venous daily dose for three days Other Names: methylprednisolone 500 mg
Active Comparator: Add-on Azithromycin Patients will receive conventional therapy and Add-on Azithromycin 500 mg single daily dose for five days	Drug: Azithromycin A single daily oral dose of Azithromycin tablet 500 mg for five days Other Names: azithromycin 500 mg oral tablet Drug: Methylprednisolone methylprednisolone 500 mg single intra-venous daily dose for three days Other Names: methylprednisolone 500 mg

Arm

Intervention/Treatment

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.

Drug: Methylprednisolone

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

Other Names:

methylprednisolone 500 mg

Active Comparator: Add-on Azithromycin

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

Drug: Azithromycin

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

Other Names:

azithromycin 500 mg oral tablet

Drug: Methylprednisolone

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

Other Names:

methylprednisolone 500 mg

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.