NCT02234739

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
22 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

September 9, 2014

Status Verified

September 1, 2014

Enrollment Period

2 years

First QC Date

September 2, 2014

Last Update Submit

September 8, 2014

Conditions

Invasive Pulmonary AspergillosisCOPD

Keywords

voriconazoleCOPDinvasive pulmonary aspergillosisefficacysafety

Outcome Measures

Primary Outcomes (1)

  • 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

    2-week

Secondary Outcomes (1)

  • adverse reactions following voriconazole treatment

    2-week

Other Outcomes (1)

  • all-cause mortality of invasive pulmonary aspergillosis secondary to COPD

    2 week

Study Arms (1)

active treatment

EXPERIMENTAL

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

Drug: Voriconazole

Interventions

VoriconazoleDRUG

2-week long intravenous instillation of voriconazole

Also known as: Vfend
active treatment

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cases of invasive pulmonary aspergillosis secondary to COPD

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hangzhou Red Cross Hospital

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (4)

  • 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.

    PMID: 24135224BACKGROUND

  • 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.

    PMID: 21385144BACKGROUND

  • 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.

    PMID: 19684861BACKGROUND

  • 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.

    PMID: 18177225BACKGROUND

MeSH Terms

Conditions

Invasive Pulmonary AspergillosisPulmonary Disease, Chronic Obstructive

Interventions

Voriconazole

Condition Hierarchy (Ancestors)

Pulmonary AspergillosisAspergillosisMycosesBacterial Infections and MycosesInfectionsInvasive Fungal InfectionsLung Diseases, FungalLung DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Chuang Cai, doctor

    Red Cross Hospital, Hangzhou, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chuang Cai, doctor

CONTACT

86-0571-56109772tinattm@163.com

Zhijian Bao, master

CONTACT

86-0571-56109707baozhijian@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

September 2, 2014

First Posted

September 9, 2014

Study Start

October 1, 2014

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

September 9, 2014

Record last verified: 2014-09

Locations

CN(1)