Efficacy and Safety of Caspofungin for 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.
Invasive Pulmonary Aspergillosis
Chronic Obstructive Pulmonary Disease
|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|
- 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.
- 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 ]
|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)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499433
|Contact: Feng Ye, MDfirstname.lastname@example.org|
|Guangzhou Institute of Respiratory Diseases||Recruiting|
|Guangzhou, Guangdong, China, 510120|
|Contact: Nanshan Zhong, MD 862083062888 Nanshan@vip.163.com|
|Principal Investigator: Feng Ye, MD|
|Principal Investigator:||Feng Ye, MD||Guangzhou Institute of Respiratory Disease|