Voriconazole for IPA in Chinese Patients With COPD (VIA-COPD)

September 8, 2014 updated by: caichuang, Red Cross Hospital, Hangzhou, China

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chuang Cai, doctor
  • Phone Number: 86-0571-56109772
  • Email: tinattm@163.com

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Hangzhou Red Cross Hospital
        • Contact:
        • Sub-Investigator:
          • Enguo Chen, doctor
        • Sub-Investigator:
          • Limin Wang, master
        • Sub-Investigator:
          • Qun Nv, bachelor
        • Sub-Investigator:
          • Rongzhuan Zhao, bachelor
        • Sub-Investigator:
          • YongChen Li, bachelor
        • Sub-Investigator:
          • Xiaoping Huang, bachelor
        • Sub-Investigator:
          • Bin Wang, bachelor
        • Sub-Investigator:
          • jianping Yan, bachelor
        • Sub-Investigator:
          • jianpu Xu, bachelor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: active treatment
Chinese patients with invasive pulmonary aspergillosis treated by voriconazole, who has COPD as underlying condition
Drug: Voriconazole
2-week long intravenous instillation of voriconazole
Other Names:
  • Vfend

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2-week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse reactions following voriconazole treatment
Time Frame: 2-week
any adverse events including complaints, physical signs, or laboratory abnormalities
2-week

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause mortality of invasive pulmonary aspergillosis secondary to COPD
Time Frame: 2 week
all-cause mortality
2 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Red Cross Hospital, Hangzhou, China

Collaborators

First People's Hospital of Hangzhou
Sir Run Run Shaw Hospital
Zhejiang Provincial People's Hospital
Second People's Hospital of Hangzhou
The Third Affiliated hospital of Zhejiang Chinese Medical University
Ningbo People's Hospital
Xiaoshan People's Hospital
Xiaoshan Hospital
The First People's Hospital of Huzhou

Investigators

  • Principal Investigator: Chuang Cai, doctor, Red Cross Hospital, Hangzhou, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

September 2, 2014

First Submitted That Met QC Criteria

September 8, 2014

First Posted (Estimate)

September 9, 2014

Study Record Updates

Last Update Posted (Estimate)

September 9, 2014

Last Update Submitted That Met QC Criteria

September 8, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hangzhou Red Cross Hospital

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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