Trial | NCT02234739  Report issue

Title

Voriconazole for IPA in Chinese Patients With COPD
Efficacy and Safety of Voriconazole for Treatment of Invasive Pulmonary Aspergillosis Secondary to COPD: a Multi-center Prospective，Open Cohort Study (VIA-COPD)

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    40
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.
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.
Study Started
Oct 31
2014
Primary Completion
Oct 31
2016
Anticipated
Study Completion
Dec 31
2016
Anticipated
Last Update
Sep 09
2014
Estimate

Drug Voriconazole

2-week long intravenous instillation of voriconazole

  • Other names: Vfend

active treatment Experimental

Chinese patients with invasive pulmonary aspergillosis treated by voriconazole, who has COPD as underlying condition

Criteria 

Inclusion Criteria:

Cases of invasive pulmonary aspergillosis secondary to COPD

Exclusion Criteria:

Use of voriconazole or itraconazole or amphotericin B or caspofungin or micafungin within 4 weeks prior to enrollment
Known allergy to voriconazole
Severe impairment of live or kidney function
Septic shock
Unwilling to sign informed consent
No Results Posted