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

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ClinicalTrials.gov Identifier: NCT02234739
Recruitment Status : Unknown
Verified September 2014 by caichuang, Red Cross Hospital, Hangzhou, China.
Recruitment status was:  Not yet recruiting
First Posted : September 9, 2014
Last Update Posted : September 9, 2014
Sponsor:
Collaborators:
Sir Run Run Shaw Hospital
Zhejiang Provincial People’s Hospital
First People's Hospital of Hangzhou
Second People's Hospital of Hangzhou
Hangzhou Hospital of Traditional Chinese Medicine
Ningbo People's Hospital
Xiaoshan People's Hospital
Xiaoshan Hospital
First People's Hospital Affiliated to Huzhou University
Information provided by (Responsible Party):
caichuang, 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.

Condition or disease Intervention/treatment Phase
Invasive Pulmonary Aspergillosis COPD Drug: Voriconazole Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

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 Name: Vfend




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. adverse reactions following voriconazole treatment [ Time Frame: 2-week ]
    any adverse events including complaints, physical signs, or laboratory abnormalities


Other Outcome Measures:
  1. all-cause mortality of invasive pulmonary aspergillosis secondary to COPD [ Time Frame: 2 week ]
    all-cause mortality



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234739


Contacts
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Contact: Chuang Cai, doctor 86-0571-56109772 tinattm@163.com
Contact: Zhijian Bao, master 86-0571-56109707 baozhijian@163.com

Locations
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China, Zhejiang
Hangzhou Red Cross Hospital Not yet recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Chuang Cai, doctor    86-0571-56109772    tinattm@163.com   
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         
Sponsors and Collaborators
Red Cross Hospital, Hangzhou, China
Sir Run Run Shaw Hospital
Zhejiang Provincial People’s Hospital
First People's Hospital of Hangzhou
Second People's Hospital of Hangzhou
Hangzhou Hospital of Traditional Chinese Medicine
Ningbo People's Hospital
Xiaoshan People's Hospital
Xiaoshan Hospital
First People's Hospital Affiliated to Huzhou University
Investigators
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Principal Investigator: Chuang Cai, doctor Hangzhou Red Cross Hospital

Publications:
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Responsible Party: caichuang, professor, Red Cross Hospital, Hangzhou, China
ClinicalTrials.gov Identifier: NCT02234739     History of Changes
Other Study ID Numbers: Hangzhou Red Cross Hospital
First Posted: September 9, 2014    Key Record Dates
Last Update Posted: September 9, 2014
Last Verified: September 2014
Keywords provided by caichuang, Red Cross Hospital, Hangzhou, China:
voriconazole
COPD
invasive pulmonary aspergillosis
efficacy
safety
Additional relevant MeSH terms:
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Aspergillosis
Pulmonary Aspergillosis
Invasive Pulmonary Aspergillosis
Lung Diseases
Respiratory Tract Diseases
Mycoses
Lung Diseases, Fungal
Invasive Fungal Infections
Voriconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors