Efficacy of azithromycin for treatment of acute exacerbation of chronic fibrosing interstitial pneumonia: a prospective, open-label study with historical controls

Respiration. 2014;87(6):478-84. doi: 10.1159/000358443. Epub 2014 Apr 30.

Abstract

Background: Acute exacerbation of chronic fibrosing interstitial pneumonia (AE-CFIP) is an often fatal condition with no established treatment. Recently, macrolides were found to be beneficial in cases of acute lung injury.

Objectives: To examine the clinical effectiveness and safety of intravenous azithromycin in patients hospitalized for AE-CFIP.

Methods: A prospective, open-label study with historical controls was conducted. Twenty consecutive patients with AE-CFIP received azithromycin. They were compared with a historical cohort treated with fluoroquinolone (n = 56). All patients received high-dose steroid pulse therapy. The primary end point was mortality at 60 days. The secondary end point was safety of intravenous azithromycin in patients with AE-CFIP. Inverse probability of treatment weighting (IPTW) using the propensity score was performed to investigate the relationship between azithromycin use and survival time.

Results: Mortality was significantly lower in the patients treated with azithromycin than in those treated with fluoroquinolone (mortality rate at 60 days: 20 vs. 69.6%, p < 0.001; median survival time: not reached vs. 29.5 days, p < 0.001). The IPTW adjusted hazard of mortality at 60 days in patients receiving azithromycin was 0.17 (95% CI 0.05-0.61). No serious adverse events were observed.

Conclusions: Azithromycin was associated with improved outcomes in patients with AE-CFIP. Further studies are needed to verify this finding (Clinical trial JMA-IIA00095).

Publication types

  • Comparative Study

MeSH terms

  • Administration, Intravenous
  • Aged
  • Aged, 80 and over
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / adverse effects
  • Azithromycin* / administration & dosage
  • Azithromycin* / adverse effects
  • Chronic Disease
  • Disease Progression
  • Dose-Response Relationship, Drug
  • Drug Monitoring
  • Drug Therapy, Combination / methods
  • Female
  • Fluoroquinolones* / administration & dosage
  • Fluoroquinolones* / adverse effects
  • Humans
  • Japan / epidemiology
  • Lung Diseases, Interstitial* / diagnosis
  • Lung Diseases, Interstitial* / drug therapy
  • Lung Diseases, Interstitial* / mortality
  • Lung Diseases, Interstitial* / physiopathology
  • Male
  • Prospective Studies
  • Steroids* / administration & dosage
  • Steroids* / adverse effects
  • Survival Analysis
  • Treatment Outcome

Substances

  • Anti-Bacterial Agents
  • Fluoroquinolones
  • Steroids
  • Azithromycin