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

Prospective, Open-label Study of the Efficacy and Safety of Caspofungin for the Treatment of Invasive Pulmonary Aspergillosis Underlying Chronic Obstructive Pulmonary Disease

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease; Invasive Pulmonary Aspergillosis
• Intervention / Treatment: Drug: caspofungin

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Feng Ye, MD; Phone Number: 862083062836; Email: yefeng@gird.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Guangzhou Institute of Respiratory Diseases
      • Contact: Nanshan Zhong, MD; Phone Number: 862083062888; Email: Nanshan@vip.163.com
      • Principal Investigator: Feng Ye, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: 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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Feng Ye, MD, Guangzhou Institute of Respiratory Disease

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): September 1, 2014
• Study Completion (Anticipated): November 1, 2014

Study Registration Dates

• First Submitted: December 16, 2011
• First Submitted That Met QC Criteria: December 22, 2011
• First Posted (Estimate): December 26, 2011

Study Record Updates

• Last Update Posted (Estimate): January 23, 2014
• Last Update Submitted That Met QC Criteria: January 22, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Bacterial Infections and Mycoses; Mycoses; Invasive Fungal Infections; Lung Diseases, Fungal; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Aspergillosis; Pulmonary Aspergillosis; Invasive Pulmonary Aspergillosis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antifungal Agents; Caspofungin
• Other Study ID Numbers: IISP# 39758