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

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ClinicalTrials.gov Identifier: NCT01499433
Recruitment Status : Unknown
Verified January 2014 by Feng Ye, The First Affiliated Hospital of Guangzhou Medical University.
Recruitment status was:  Recruiting
First Posted : December 26, 2011
Last Update Posted : January 23, 2014
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Feng Ye, The First Affiliated Hospital of Guangzhou Medical University

December 16, 2011
December 26, 2011
January 23, 2014
January 2012
September 2014   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01499433 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Caspofungin for Invasive Pulmonary Aspergillosis Underlying Chronic Obstructive Pulmonary Disease
Prospective, Open-label Study of the Efficacy and Safety of Caspofungin for the Treatment of Invasive Pulmonary Aspergillosis Underlying Chronic Obstructive Pulmonary Disease
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.
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.
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Invasive Pulmonary Aspergillosis
  • Chronic Obstructive Pulmonary Disease
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
Experimental: caspofungin
Intervention: Drug: caspofungin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
Same as current
November 2014
September 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01499433
IISP# 39758
Yes
Not Provided
Not Provided
Feng Ye, The First Affiliated Hospital of Guangzhou Medical University
The First Affiliated Hospital of Guangzhou Medical University
Merck Sharp & Dohme Corp.
Principal Investigator: Feng Ye, MD Guangzhou Institute of Respiratory Disease
The First Affiliated Hospital of Guangzhou Medical University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP