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

This study is currently recruiting participants.
Verified March 2012 by The First Affiliated Hospital of Guangzhou Medical University
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
Feng Ye, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier:
NCT01499433
First received: December 16, 2011
Last updated: March 25, 2012
Last verified: March 2012
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by 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) ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Feng Ye, MD Guangzhou Institute of Respiratory Diseases.
  More Information

No publications provided

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
Study First Received: December 16, 2011
Last Updated: March 25, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Aspergillosis
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Invasive Pulmonary Aspergillosis
Lung Diseases, Obstructive
Pulmonary Aspergillosis
Mycoses
 Respiratory Tract Diseases
Lung Diseases, Fungal
Caspofungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013