COPD, Invasive Pulmonary Aspergillosis
Conditions
Keywords
voriconazole, COPD, invasive pulmonary aspergillosis, efficacy, safety
Brief summary
voriconazole is recommended as first-line therapy for invasive pulmonary aspergillosis, however the efficacy and safety of voriconazole for treating invasive pulmonary aspergillosis secondary to COPD is not clear. This study aims to investigate the effectiveness and tolerability of intravenous voriconazole for treatment of invasive pulmonary aspergillosis in Chinese patients with COPD, by monitoring changes in clinical symptoms, eradication of aspergillus, improvement of chest imaging as well as record of possible adverse reactions following 2-week intravenous instillation of voriconazole.
Detailed description
This is a multiple-center open-label clinical trial to study the efficacy and safety of voriconazole for treating invasive pulmonary aspergillosis secondary to COPD in Chinese patients.The primary endpoint is treatment success rate as defined by improvement of symptoms related to invasive pulmonary asperillosis, secondary endpoints include the mortality, the eradication of sputum asperillus and profile of adverse reactions following intravenous instillation of voriconazole.
Interventions
DRUGVoriconazole
2-week long intravenous instillation of voriconazole
Sponsors
Sir Run Run Shaw Hospital
Zhejiang Provincial People's Hospital
First People's Hospital of Hangzhou
Second People's Hospital of Hangzhou
The Third Affiliated hospital of Zhejiang Chinese Medical University
Ningbo People's Hospital
Xiaoshan People's Hospital
Xiaoshan Hospital
The First People's Hospital of Huzhou
Red Cross Hospital, Hangzhou, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Cases of invasive pulmonary aspergillosis secondary to COPD
Exclusion criteria
* Use of voriconazole or itraconazole or amphotericin B or caspofungin or micafungin within 4 weeks prior to enrollment * Known allergy to voriconazole * Severe impairment of live or kidney function * Septic shock * Unwilling to sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| success rate of voriconazole antifungal treatment | 2-week | treatment success if defined as improve of symptoms related to invasive pulmonary aspergillosis, such as fever, wheezing, chest pain, dyspnea, and hemoptysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse reactions following voriconazole treatment | 2-week | any adverse events including complaints, physical signs, or laboratory abnormalities |
Other
| Measure | Time frame | Description |
|---|---|---|
| all-cause mortality of invasive pulmonary aspergillosis secondary to COPD | 2 week | all-cause mortality |
Countries
China
Contacts
Primary ContactChuang Cai, doctor
Backup ContactZhijian Bao, master
Outcome results
None listed