Voriconazole for IPA in Chinese Patients With COPD

NCT ID: NCT02234739

Last Updated: 2014-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Invasive Pulmonary Aspergillosis COPD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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active treatment

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

Group Type EXPERIMENTAL

Voriconazole

Intervention Type DRUG

2-week long intravenous instillation of voriconazole

Interventions

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Voriconazole

2-week long intravenous instillation of voriconazole

Intervention Type DRUG

Other Intervention Names

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Vfend

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sir Run Run Shaw Hospital

OTHER

Sponsor Role collaborator

Zhejiang Provincial People's Hospital

OTHER

Sponsor Role collaborator

First People's Hospital of Hangzhou

OTHER

Sponsor Role collaborator

Second People's Hospital of Hangzhou

UNKNOWN

Sponsor Role collaborator

The Third Affiliated hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role collaborator

Ningbo People's Hospital

UNKNOWN

Sponsor Role collaborator

Xiaoshan People's Hospital

OTHER

Sponsor Role collaborator

Xiaoshan Hospital

UNKNOWN

Sponsor Role collaborator

The First People's Hospital of Huzhou

OTHER

Sponsor Role collaborator

Red Cross Hospital, Hangzhou, China

OTHER

Sponsor Role lead

Responsible Party

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caichuang

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chuang Cai, doctor

Role: PRINCIPAL_INVESTIGATOR

Red Cross Hospital, Hangzhou, China

Locations

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Hangzhou Red Cross Hospital

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Chuang Cai, doctor

Role: CONTACT

86-0571-56109772

Zhijian Bao, master

Role: CONTACT

86-0571-56109707

Facility Contacts

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Chuang Cai, doctor

Role: primary

86-0571-56109772

References

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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.

Reference Type BACKGROUND
PMID: 24135224 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21385144 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19684861 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18177225 (View on PubMed)

Other Identifiers

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Hangzhou Red Cross Hospital

Identifier Type: -

Identifier Source: org_study_id

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