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

December 16, 2011
March 25, 2012
January 2012
November 2013   (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) ] [ 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.
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. ] [ 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 ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Recruiting
40
December 2013
November 2013   (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
Both
18 Years and older
No
Contact: Feng Ye, MD 862083062836 yefeng@gird.cn
China
 
NCT01499433
IISP# 39758
Yes
Feng Ye, The First Affiliated Hospital of Guangzhou Medical University
The First Affiliated Hospital of Guangzhou Medical University
Merck
Principal Investigator: Feng Ye, MD Guangzhou Institute of Respiratory Diseases.
The First Affiliated Hospital of Guangzhou Medical University
March 2012

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