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

Phase 4

• Conditions: Invasive Pulmonary Aspergillosis; Chronic Obstructive Pulmonary Disease
• Interventions: Drug: caspofungin

• Registration Number: NCT01499433
• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University

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.

Study Timeline

• Study First Submitted: 2011-12-16
• Study First Submitted QC: 2011-12-22
• Study First Posted: 2011-12-26
• Study Start: 2012-01
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-22
• Last Update Posted: 2014-01-23
• Primary Completion: 2014-09
• Study Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
caspofungin	caspofungin	-

Primary Outcome Measures

Name	Time	Method
Global response (defined as both clinical and microbiologic success) at the end of intravenous therapy	At end of intravenous treatment(three week)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Guangzhou Institute of Respiratory Diseases; 🇨🇳 Guangzhou, Guangdong, China