Clinical Trial: Voriconazole for IPA in Chinese Patients With COPD

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Efficacy and Safety of Voriconazole for Treatment of Invasive Pulmonary Aspergillosis Secondary to COPD: a Multi-center Prospective，Open Cohort Study (VIA-COPD)

Brief Summary: voriconazole is recommended as first-line therapy for invasive pulmonary aspergillosis, however the efficacy and safety of voriconazole for treating invasive pulmonary aspergillosis secondary to COPD is not clear. This study aims to investigate the effectiveness and tolerability of intravenous voriconazole for treatment of invasive pulmonary aspergillosis in Chinese patients with COPD, by monitoring changes in clinical symptoms, eradication of aspergillus, improvement of chest imaging as well as record of possible adverse reactions following 2-week intravenous instillation of voriconazole.

Detailed Summary: This is a multiple-center open-label clinical trial to study the efficacy and safety of voriconazole for treating invasive pulmonary aspergillosis secondary to COPD in Chinese patients.The primary endpoint is treatment success rate as defined by improvement of symptoms related to invasive pulmonary asperillosis, secondary endpoints include the mortality, the eradication of sputum asperillus and profile of adverse reactions following intravenous instillation of voriconazole.
Sponsor: Red Cross Hospital, Hangzhou, China

Current Primary Outcome: success rate of voriconazole antifungal treatment [ Time Frame: 2-week ]

treatment success if defined as improve of symptoms related to invasive pulmonary aspergillosis, such as fever, wheezing, chest pain, dyspnea, and hemoptysis


Original Primary Outcome: Same as current

Current Secondary Outcome: adverse reactions following voriconazole treatment [ Time Frame: 2-week ]

any adverse events including complaints, physical signs, or laboratory abnormalities


Original Secondary Outcome: Same as current

Information By: Red Cross Hospital, Hangzhou, China

Dates:
Date Received: September 2, 2014
Date Started: October 2014
Date Completion: December 2016
Last Updated: September 8, 2014
Last Verified: September 2014