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Efficacy and Safety of Caspofungin for Invasive Pulmonary Aspergillosis Underlying Chronic Obstructive Pulmonary Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by Feng Ye, The First Affiliated Hospital of Guangzhou Medical University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01499433
First Posted: December 26, 2011
Last Update Posted: January 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Feng Ye, The First Affiliated Hospital of Guangzhou Medical University
  Purpose
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.

Condition Intervention Phase
Invasive Pulmonary Aspergillosis Chronic Obstructive Pulmonary Disease Drug: caspofungin Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Feng Ye, The First Affiliated Hospital of Guangzhou Medical University:

Primary Outcome Measures:
  • Global response (defined as both clinical and microbiologic success) at the end of intravenous therapy [ Time Frame: At end of intravenous treatment(three week) ]
    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 [ Time Frame: at the time of enrollment, weekly during therapy, and 1 week after the end of therapy. ]
    Safety evaluation : Laboratory examinations are performed; Number of participants with adverse events are recorded.

  • Global response to 2-week caspofungin therapy [ Time Frame: 2 week ]
  • Factors such as severity of COPD, exposure to systemic corticosteroids,extended-spectrum antibiotics et al. affecting patients' response to caspofungin therapy [ Time Frame: 3 week ]
    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 [ Time Frame: 1 week ]

Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: caspofungin Drug: caspofungin
Caspofungin injection, intravenously administered, loading dose at 70mg qd for the first 24hrs, maintenance dose at 50mg qd for the following 20 days
Other Name: brand name:Cancidas

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.
  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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): NCT01499433


Contacts
Contact: Feng Ye, MD 862083062836 yefeng@gird.cn

Locations
China, Guangdong
Guangzhou Institute of Respiratory Diseases Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Nanshan Zhong, MD    862083062888    Nanshan@vip.163.com   
Principal Investigator: Feng Ye, MD         
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Feng Ye, MD Guangzhou Institute of Respiratory Disease
  More Information

Responsible Party: Feng Ye, Principal Investigator, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT01499433     History of Changes
Other Study ID Numbers: IISP# 39758
First Submitted: December 16, 2011
First Posted: December 26, 2011
Last Update Posted: January 23, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Aspergillosis
Pulmonary Aspergillosis
Invasive Pulmonary Aspergillosis
Respiratory Tract Diseases
Mycoses
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases
Invasive Fungal Infections
Caspofungin
Echinocandins
Antifungal Agents
Anti-Infective Agents