Clinical trial NCT01499433: Efficacy and Safety of Caspofungin for Invasive Pulmonary Aspergillosis Underlying Chronic Obstructive Pulmonary Disease
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Invasive Pulmonary Aspergillosis
Chronic Obstructive Pulmonary Disease
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-12-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Global response (defined as both clinical and microbiologic success) at the end of intravenous therapy
timeFrame: At end of intravenous treatment(three week)
Secondary outcomes:
measure: Assessment of Safety of Caspofungin for IPA Underlying COPD
timeFrame: at the time of enrollment, weekly during therapy, and 1 week after the end of therapy.
measure: Global response to 2-week caspofungin therapy
timeFrame: 2 week
measure: Factors such as severity of COPD, exposure to systemic corticosteroids,extended-spectrum antibiotics et al. affecting patients' response to caspofungin therapy
timeFrame: 3 week
measure: Clinical response at Day 7 of treatment
timeFrame: 1 week
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Institute of Respiratory Diseases
state: Guangdong
Study officials:
affiliation: Guangzhou Institute of Respiratory Disease
name: Feng Ye, MD
role: PRINCIPAL_INVESTIGATOR
References: