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

Primary Purpose

Invasive Pulmonary Aspergillosis, COPD

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Voriconazole
Sponsored by
Red Cross Hospital, Hangzhou, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Invasive Pulmonary Aspergillosis focused on measuring voriconazole, COPD, invasive pulmonary aspergillosis, efficacy, safety

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hangzhou Red Cross Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

active treatment

Arm Description

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

Outcomes

Primary Outcome Measures

success rate of voriconazole antifungal treatment
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

adverse reactions following voriconazole treatment
any adverse events including complaints, physical signs, or laboratory abnormalities

Full Information

First Posted
September 2, 2014
Last Updated
September 8, 2014
Sponsor
Red Cross Hospital, Hangzhou, China
Collaborators
Sir Run Run Shaw Hospital, Zhejiang Provincial People's Hospital, First People's Hospital of Hangzhou, 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
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1. Study Identification

Unique Protocol Identification Number
NCT02234739
Brief Title
Voriconazole for IPA in Chinese Patients With COPD
Acronym
VIA-COPD
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Red Cross Hospital, Hangzhou, China
Collaborators
Sir Run Run Shaw Hospital, Zhejiang Provincial People's Hospital, First People's Hospital of Hangzhou, 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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Pulmonary Aspergillosis, COPD
Keywords
voriconazole, COPD, invasive pulmonary aspergillosis, efficacy, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
active treatment
Arm Type
Experimental
Arm Description
Chinese patients with invasive pulmonary aspergillosis treated by voriconazole, who has COPD as underlying condition
Intervention Type
Drug
Intervention Name(s)
Voriconazole
Other Intervention Name(s)
Vfend
Intervention Description
2-week long intravenous instillation of voriconazole
Primary Outcome Measure Information:
Title
success rate of voriconazole antifungal treatment
Description
treatment success if defined as improve of symptoms related to invasive pulmonary aspergillosis, such as fever, wheezing, chest pain, dyspnea, and hemoptysis
Time Frame
2-week
Secondary Outcome Measure Information:
Title
adverse reactions following voriconazole treatment
Description
any adverse events including complaints, physical signs, or laboratory abnormalities
Time Frame
2-week
Other Pre-specified Outcome Measures:
Title
all-cause mortality of invasive pulmonary aspergillosis secondary to COPD
Description
all-cause mortality
Time Frame
2 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chuang Cai, doctor
Phone
86-0571-56109772
Email
tinattm@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhijian Bao, master
Phone
86-0571-56109707
Email
baozhijian@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chuang Cai, doctor
Organizational Affiliation
Red Cross Hospital, Hangzhou, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hangzhou Red Cross Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuang Cai, doctor
Phone
86-0571-56109772
Email
tinattm@163.com
First Name & Middle Initial & Last Name & Degree
Enguo Chen, doctor
First Name & Middle Initial & Last Name & Degree
Limin Wang, master
First Name & Middle Initial & Last Name & Degree
Qun Nv, bachelor
First Name & Middle Initial & Last Name & Degree
Rongzhuan Zhao, bachelor
First Name & Middle Initial & Last Name & Degree
YongChen Li, bachelor
First Name & Middle Initial & Last Name & Degree
Xiaoping Huang, bachelor
First Name & Middle Initial & Last Name & Degree
Bin Wang, bachelor
First Name & Middle Initial & Last Name & Degree
jianping Yan, bachelor
First Name & Middle Initial & Last Name & Degree
jianpu Xu, bachelor

12. IPD Sharing Statement

Citations:
PubMed Identifier
24135224
Citation
Tutar N, Metan G, Koc AN, Yilmaz I, Bozkurt I, Simsek ZO, Buyukoglan H, Kanbay A, Oymak FS, Gulmez I, Demir R. Invasive pulmonary aspergillosis in patients with chronic obstructive pulmonary disease. Multidiscip Respir Med. 2013 Sep 4;8(1):59. doi: 10.1186/2049-6958-8-59. eCollection 2013.
Results Reference
background
PubMed Identifier
21385144
Citation
Patel DA, Gao X, Stephens JM, Forshag MS, Tarallo M. US hospital database analysis of invasive aspergillosis in the chronic obstructive pulmonary disease non-traditional host. J Med Econ. 2011;14(2):227-37. doi: 10.3111/13696998.2011.564246. Epub 2011 Mar 9.
Results Reference
background
PubMed Identifier
19684861
Citation
Ader F, Bienvenu AL, Rammaert B, Nseir S. Management of invasive aspergillosis in patients with COPD: rational use of voriconazole. Int J Chron Obstruct Pulmon Dis. 2009;4:279-87. doi: 10.2147/copd.s4229. Epub 2009 Aug 3.
Results Reference
background
PubMed Identifier
18177225
Citation
Walsh TJ, Anaissie EJ, Denning DW, Herbrecht R, Kontoyiannis DP, Marr KA, Morrison VA, Segal BH, Steinbach WJ, Stevens DA, van Burik JA, Wingard JR, Patterson TF; Infectious Diseases Society of America. Treatment of aspergillosis: clinical practice guidelines of the Infectious Diseases Society of America. Clin Infect Dis. 2008 Feb 1;46(3):327-60. doi: 10.1086/525258. No abstract available.
Results Reference
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Voriconazole for IPA in Chinese Patients With COPD

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