Efficacy and Safety of Caspofungin for Invasive Pulmonary Aspergillosis Underlying Chronic Obstructive Pulmonary Disease
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: caspofungin
|
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 Names:
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Outcome Measures
Primary Outcome Measures
- Global response (defined as both clinical and microbiologic success) at the end of intravenous therapy [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.
Secondary Outcome Measures
- Assessment of Safety of Caspofungin for IPA Underlying COPD [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 [2 week]
- Factors such as severity of COPD, exposure to systemic corticosteroids,extended-spectrum antibiotics et al. affecting patients' response to caspofungin therapy [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 [1 week]
Eligibility Criteria
Criteria
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:
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A history of allergy to echinocandins
-
Severe renal failure, severe hepatic insufficiency
-
Inadequately treated bacterial infection
-
Documented HIV infection
-
Status of pregnancy or lactation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Guangzhou Institute of Respiratory Diseases | Guangzhou | Guangdong | China | 510120 |
Sponsors and Collaborators
- The First Affiliated Hospital of Guangzhou Medical University
- Merck Sharp & Dohme LLC
Investigators
- Principal Investigator: Feng Ye, MD, Guangzhou Institute of Respiratory Disease
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IISP# 39758