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

Information source: The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Invasive Pulmonary Aspergillosis; Chronic Obstructive Pulmonary Disease

Intervention: caspofungin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: The First Affiliated Hospital of Guangzhou Medical University

Official(s) and/or principal investigator(s):
Feng Ye, MD, Principal Investigator, Affiliation: Guangzhou Institute of Respiratory Disease

Overall contact:
Feng Ye, MD, Phone: 862083062836, Email: yefeng@gird.cn

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.

Clinical Details

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

Primary outcome: Global response (defined as both clinical and microbiologic success) at the end of intravenous therapy

Secondary outcome:

Assessment of Safety of Caspofungin for IPA Underlying COPD

Global response to 2-week caspofungin therapy

Factors such as severity of COPD, exposure to systemic corticosteroids,extended-spectrum antibiotics et al. affecting patients' response to caspofungin therapy

Clinical response at Day 7 of treatment

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Feng Ye, MD, Phone: 862083062836, Email: yefeng@gird.cn

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

Starting date: January 2012
Last updated: January 22, 2014

Page last updated: August 20, 2015

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