Voriconazole for IPA in Chinese Patients With COPD

Phase 4

• Conditions: Invasive Pulmonary Aspergillosis; COPD
• Interventions: Drug: Voriconazole

• Registration Number: NCT02234739
• Lead Sponsor: Red Cross Hospital, Hangzhou, China

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 Description

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 Timeline

• Status Verified: 2014-09
• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2014-09-08
• Last Update Submitted: 2014-09-08
• Study First Posted: 2014-09-09
• Last Update Posted: 2014-09-09
• Study Start: 2014-10
• Primary Completion: 2016-10
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
active treatment	Voriconazole	Chinese patients with invasive pulmonary aspergillosis treated by voriconazole, who has COPD as underlying condition

Primary Outcome Measures

Name	Time	Method
success rate of voriconazole antifungal treatment	2-week	treatment success if defined as improve of symptoms related to invasive pulmonary aspergillosis, such as fever, wheezing, chest pain, dyspnea, and hemoptysis

Secondary Outcome Measures

Name	Time	Method
adverse reactions following voriconazole treatment	2-week	any adverse events including complaints, physical signs, or laboratory abnormalities

Trial Locations

Locations (1)

Hangzhou Red Cross Hospital; 🇨🇳 Hangzhou, Zhejiang, China