Chronic Obstructive Pulmonary Disease, Invasive Pulmonary Aspergillosis
Conditions
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.
Interventions
DRUGcaspofungin
Caspofungin injection, intravenously administered, loading dose at 70mg qd for the first 24hrs, maintenance dose at 50mg qd for the following 20 days
Sponsors
Merck Sharp & Dohme LLC
The First Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
China
Contacts
Primary ContactFeng Ye, MD
Outcome results
None listed