Efficacy and Safety of Caspofungin for Invasive Pulmonary Aspergillosis Underlying Chronic Obstructive Pulmonary Disease
| Tracking Information | |||||
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| First Received Date ICMJE | December 16, 2011 | ||||
| Last Updated Date | March 25, 2012 | ||||
| Start Date ICMJE | January 2012 | ||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01499433 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy and Safety of Caspofungin for Invasive Pulmonary Aspergillosis Underlying Chronic Obstructive Pulmonary Disease | ||||
| Official Title ICMJE | Prospective, Open-label Study of the Efficacy and Safety of Caspofungin for the Treatment of Invasive Pulmonary Aspergillosis Underlying Chronic Obstructive Pulmonary Disease | ||||
| 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Arm (s) | Experimental: caspofungin
Intervention: Drug: caspofungin |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | November 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01499433 | ||||
| Other Study ID Numbers ICMJE | IISP# 39758 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Feng Ye, The First Affiliated Hospital of Guangzhou Medical University | ||||
| Study Sponsor ICMJE | The First Affiliated Hospital of Guangzhou Medical University | ||||
| Collaborators ICMJE | Merck | ||||
| Investigators ICMJE |
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| Information Provided By | The First Affiliated Hospital of Guangzhou Medical University | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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