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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Prospective, Open-label Study of the Efficacy and Safety of Caspofungin for the Treatment of Invasive Pulmonary Aspergillosis Underlying Chronic Obstructive Pulmonary Dise

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 Summary: 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.
Sponsor: The First Affiliated Hospital of Guangzhou Medical University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: The First Affiliated Hospital of Guangzhou Medical University

Dates:
Date Received: December 16, 2011
Date Started: January 2012
Date Completion: November 2014
Last Updated: January 22, 2014
Last Verified: January 2014