Efficacy and Safety of Caspofungin for Invasive Pulmonary Aspergillosis Underlying Chronic Obstructive Pulmonary Disease
Primary Purpose
Invasive Pulmonary Aspergillosis, Chronic Obstructive Pulmonary Disease
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
caspofungin
Sponsored by
About this trial
This is an interventional treatment trial for Invasive Pulmonary Aspergillosis
Eligibility Criteria
Inclusion Criteria:
- Proven invasive pulmonary aspergillosis
- Probable invasive pulmonary aspergillosis
- Hospitalized in respiratory wards
- Not having received an empirical antifungal therapy for 72h before inclusion
Exclusion Criteria:
- A history of allergy to echinocandins
- Severe renal failure, severe hepatic insufficiency
- Inadequately treated bacterial infection
- Documented HIV infection
- Status of pregnancy or lactation
Sites / Locations
- Guangzhou Institute of Respiratory DiseasesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
caspofungin
Arm Description
Outcomes
Primary Outcome Measures
Global response (defined as both clinical and microbiologic success) at the end of intravenous therapy
The primary objective is to investigate the clinical efficacy of 3-week treatment with caspofungin as either primary or salvage antifungal therapy for IPA underlying COPD.
Secondary Outcome Measures
Assessment of Safety of Caspofungin for IPA Underlying COPD
Safety evaluation : Laboratory examinations are performed; Number of participants with adverse events are recorded.
Global response to 2-week caspofungin therapy
Factors such as severity of COPD, exposure to systemic corticosteroids,extended-spectrum antibiotics et al. affecting patients' response to caspofungin therapy
Assessment of factors such as severity of COPD, exposure to systemic corticosteroids,extended-spectrum antibiotics,malnutrition or diabetes affecting patients' response to caspofungin therapy
Clinical response at Day 7 of treatment
Full Information
NCT ID
NCT01499433
First Posted
December 16, 2011
Last Updated
January 22, 2014
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01499433
Brief Title
Efficacy and Safety of Caspofungin for Invasive Pulmonary Aspergillosis Underlying Chronic Obstructive Pulmonary Disease
Official Title
Prospective, Open-label Study of the Efficacy and Safety of Caspofungin for the Treatment of Invasive Pulmonary Aspergillosis Underlying Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Guangzhou Medical University
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators propose to study the efficacy and safety of three-week antifungal therapy with caspofungin in hospitalized patients with proven or probable IPA underlying chronic obstructive pulmonary disease.
Detailed Description
Recently, there has been increasing appreciation of chronic obstructive pulmonary disease (COPD) as an important risk factor of invasive pulmoanry aspergillosis (IPA). However, clinical data on the morbidity and mortality of IPA underlying COPD as well as the efficacy and safety of antifungal treatment in such subset of patient population is very limited. In clinical pratice, capofungin is often used as primary antifungal therapy for IPA, especially in patients with impaired renal function. Based on this data, the investigators propose to study the efficacy and safety of three-week antifungal therapy with caspofungin in hospitalized patients with proven or probable IPA underlying COPD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Pulmonary Aspergillosis, Chronic Obstructive Pulmonary Disease
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
caspofungin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
caspofungin
Other Intervention Name(s)
brand name:Cancidas
Intervention Description
Caspofungin injection, intravenously administered, loading dose at 70mg qd for the first 24hrs, maintenance dose at 50mg qd for the following 20 days
Primary Outcome Measure Information:
Title
Global response (defined as both clinical and microbiologic success) at the end of intravenous therapy
Description
The primary objective is to investigate the clinical efficacy of 3-week treatment with caspofungin as either primary or salvage antifungal therapy for IPA underlying COPD.
Time Frame
At end of intravenous treatment(three week)
Secondary Outcome Measure Information:
Title
Assessment of Safety of Caspofungin for IPA Underlying COPD
Description
Safety evaluation : Laboratory examinations are performed; Number of participants with adverse events are recorded.
Time Frame
at the time of enrollment, weekly during therapy, and 1 week after the end of therapy.
Title
Global response to 2-week caspofungin therapy
Time Frame
2 week
Title
Factors such as severity of COPD, exposure to systemic corticosteroids,extended-spectrum antibiotics et al. affecting patients' response to caspofungin therapy
Description
Assessment of factors such as severity of COPD, exposure to systemic corticosteroids,extended-spectrum antibiotics,malnutrition or diabetes affecting patients' response to caspofungin therapy
Time Frame
3 week
Title
Clinical response at Day 7 of treatment
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Proven invasive pulmonary aspergillosis
Probable invasive pulmonary aspergillosis
Hospitalized in respiratory wards
Not having received an empirical antifungal therapy for 72h before inclusion
Exclusion Criteria:
A history of allergy to echinocandins
Severe renal failure, severe hepatic insufficiency
Inadequately treated bacterial infection
Documented HIV infection
Status of pregnancy or lactation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Ye, MD
Phone
862083062836
Email
yefeng@gird.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng Ye, MD
Organizational Affiliation
Guangzhou Institute of Respiratory Disease
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou Institute of Respiratory Diseases
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nanshan Zhong, MD
Phone
862083062888
Email
Nanshan@vip.163.com
First Name & Middle Initial & Last Name & Degree
Feng Ye, MD
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Caspofungin for Invasive Pulmonary Aspergillosis Underlying Chronic Obstructive Pulmonary Disease
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