Voriconazole for IPA in Chinese Patients With COPD | NCT02234739

Studies
Voriconazole for IPA in Chinese Patients With COPD

NCT02234739

Sponsor

Red Cross Hospital, Hangzhou, China

Status

Unknown status

Last Update Posted

Sep 9, 2014Estimated

Enrollment

40Estimated

Phase

Phase 4

Conditions

Invasive Pulmonary Aspergillosis
COPD

Interventions

Voriconazole

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Oct 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Sep 2, 2014

First Submission Date that Met QC Criteria

Sep 8, 2014

First Posted Date

Sep 9, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2014

Last Update Posted Date

Sep 9, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

caichuang, professor, Red Cross Hospital, Hangzhou, ChinaPrincipal Investigator

Lead Sponsor

Red Cross Hospital, Hangzhou, ChinaOTHER

Collaborators

Name	Class
Sir Run Run Shaw Hospital	OTHER
Zhejiang Provincial People's Hospital	OTHER
First People's Hospital of Hangzhou	OTHER
Second People's Hospital of Hangzhou

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
active treatment	Experimental	Chinese patients with invasive pulmonary aspergillosis treated by voriconazole, who has COPD as underlying condition	Drug: Voriconazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Voriconazole	Drug	2-week long intravenous instillation of voriconazole	active treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chuang Cai, doctor	Contact	86-0571-56109772		tinattm@163.com
Zhijian Bao, master	Contact	86-0571-56109707		baozhijian@163.com

Overall Officials

Name	Affiliation	Role
Chuang Cai, doctor	Red Cross Hospital, Hangzhou, China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hangzhou Red Cross Hospital		Hangzhou	Zhejiang	310003	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24135224	Background	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.
21385144	Background

ID	Term
D055744	Invasive Pulmonary Aspergillosis
D029424	Pulmonary Disease, Chronic Obstructive

ID	Term
D055732	Pulmonary Aspergillosis
D001228	Aspergillosis
D009181	Mycoses
D001423	Bacterial Infections and Mycoses

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds