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

The First Affiliated Hospital of Guangzhou Medical University40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Invasive Pulmonary Aspergillosis Chronic Obstructive Pulmonary Disease

Interventions

caspofunginDRUG

Caspofungin injection, intravenously administered, loading dose at 70mg qd for the first 24hrs, maintenance dose at 50mg qd for the following 20 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Guangzhou Institute of Respiratory Diseases

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: At end of intravenous treatment(three week)

Secondary Outcomes

Assessment of Safety of Caspofungin for IPA Underlying COPD

Safety evaluation : Laboratory examinations are performed; Number of participants with adverse events are recorded.

Time frame: at the time of enrollment, weekly during therapy, and 1 week after the end of therapy.

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

Assessment of factors such as severity of COPD, exposure to systemic corticosteroids,extended-spectrum antibiotics,malnutrition or diabetes affecting patients' response to caspofungin therapy

Time frame: 3 week

Clinical response at Day 7 of treatment

Time frame: 1 week

Central Contacts

Feng Ye, MD

CONTACT

862083062836 yefeng@gird.cn

Data from ClinicalTrials.gov

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