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

NCT01499433 | Unknown Phase 4 DMC

• 1 other identifier: IISP# 39758
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Invasive Pulmonary Aspergillosis; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

• 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

• Clinical response at Day 7 of treatment

  1 week

Study Arms (1)

caspofungin

EXPERIMENTAL

Drug: caspofungin

Interventions

caspofungin DRUG

Caspofungin injection, intravenously administered, loading dose at 70mg qd for the first 24hrs, maintenance dose at 50mg qd for the following 20 days

Also known as: brand name:Cancidas

caspofungin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Proven invasive pulmonary aspergillosis
• Probable invasive pulmonary aspergillosis
• Hospitalized in respiratory wards

You may not qualify if:

• A history of allergy to echinocandins
• Severe renal failure, severe hepatic insufficiency
• Inadequately treated bacterial infection
• Documented HIV infection
• Status of pregnancy or lactation

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Guangzhou Institute of Respiratory Diseases

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Invasive Pulmonary Aspergillosis; Pulmonary Disease, Chronic Obstructive

Interventions

Caspofungin

Condition Hierarchy (Ancestors)

Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Lung Diseases, Fungal; Lung Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Study Officials

• Feng Ye, MD

  Guangzhou Institute of Respiratory Disease

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Ye, MD

CONTACT

862083062836; yefeng@gird.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 16, 2011
• First Posted: December 26, 2011
• Study Start: January 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 23, 2014

Record last verified: 2014-01

Locations

CN (1)