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Status unknownNCT01499433Updated Jan 23, 2014

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

A Phase 4 interventional study of caspofungin in Invasive Pulmonary Aspergillosis and Chronic Obstructive Pulmonary Disease, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-23.

Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Invasive Pulmonary Aspergillosis
  • Chronic Obstructive Pulmonary Disease
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In context

Invasive Pulmonary Aspergillosis

48 studies on the registry are indexed under Invasive Pulmonary Aspergillosis; 9 are open to participants now.

This study's planned enrollment of 40 is below the median of 85 across 13 interventional studies indexed under Invasive Pulmonary Aspergillosis.

Browse Invasive Pulmonary Aspergillosis studies →

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 165 studies on the registry; 67 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    caspofungin

    Drug: caspofungin

Interventions

  • 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

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What researchers measure

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.

    Time frame: At end of intravenous treatment(three week)

Secondary outcomes

  1. Assessment of Safety of Caspofungin for IPA Underlying COPD

    Safety evaluation : Laboratory examinations are performed; Number of participants with adverse events are recorded.

    Time frame: at the time of enrollment, weekly during therapy, and 1 week after the end of therapy.

  2. Global response to 2-week caspofungin therapy

    Time frame: 2 week

  3. 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

    Time frame: 3 week

  4. Clinical response at Day 7 of treatment

    Time frame: 1 week

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Study locations

1 of 1 sites recruiting
  • Guangzhou Institute of Respiratory Diseases
    Guangzhou, Guangdong 510120, China
    • Nanshan Zhong, MD · Contact · Nanshan@vip.163.com · 862083062888
    • Feng Ye, MD · Principal investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01499433
Responsible party
Feng Ye (Principal Investigator, The First Affiliated Hospital of Guangzhou Medical University) — Principal investigator
First posted
Dec 26, 2011
Start date
Jan 2012
Primary completion
Sep 2014 (estimated)
Completion
Nov 2014 (estimated)
Last update
Jan 23, 2014

Study contacts

Feng Ye, MD
Contact
yefeng@gird.cn
862083062836
Feng Ye, MD
principal investigator · Guangzhou Institute of Respiratory Disease

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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