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

Study Overview
=================
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 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.

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

Conditions
-----------------
Invasive Pulmonary Aspergillosis, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: caspofungin


Participation Criteria
=================
Eligibility 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: A history of allergy to echinocandins Severe renal failure, severe hepatic insufficiency Inadequately treated bacterial infection Documented HIV infection Status of pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: caspofungin<br> | Drug: caspofungin<br>* Caspofungin injection, intravenously administered, loading dose at 70mg qd for the first 24hrs, maintenance dose at 50mg qd for the following 20 days<br>* Other names: brand name:Cancidas;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global response (defined as both clinical and microbiologic success) at the end of intravenous therapy | 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. | At end of intravenous treatment(three week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Safety of Caspofungin for IPA Underlying COPD | Safety evaluation : Laboratory examinations are performed; Number of participants with adverse events are recorded. | at the time of enrollment, weekly during therapy, and 1 week after the end of therapy. | 
| 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 | Assessment of factors such as severity of COPD, exposure to systemic corticosteroids,extended-spectrum antibiotics,malnutrition or diabetes affecting patients' response to caspofungin therapy | 3 week | 
| Clinical response at Day 7 of treatment |  | 1 week |