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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 80 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05842681
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Assiut University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	ahmad M shaddad
Principal Investigator Affiliation	Assiut university-Faculty of Medicine
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Egypt
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Idiopathic Pulmonary Fibrosis

Additional Details

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.

Arms & Interventions

Arms

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

Interventions

Drug: - Azithromycin

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

Drug: - Methylprednisolone

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

Contact a Trial Team

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