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
|Condition or disease||Intervention/treatment||Phase|
|Invasive Pulmonary Aspergillosis Chronic Obstructive Pulmonary Disease||Drug: caspofungin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||November 2014|
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
- 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01499433
|Contact: Feng Ye, MDemail@example.com|
|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|