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

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01499433
• Other study ID #: IISP# 39758
• Status: Recruiting
• Phase: Phase 4
• First received: December 16, 2011
• Last updated: January 22, 2014
• Start date: January 2012
• Est. completion date: November 2014

Study information

• Verified date: January 2014
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: Feng Ye, MD
• Phone: 862083062836
• Email: yefeng[@]gird.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aspergillosis
• Chronic Obstructive Pulmonary Disease
• Invasive Pulmonary Aspergillosis
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Aspergillosis
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
China	Guangzhou Institute of Respiratory Diseases	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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.	Yes
Secondary	Global response to 2-week caspofungin therapy		2 week	No
Secondary	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	No
Secondary	Clinical response at Day 7 of treatment		1 week	No