Clinical trial NCT02234739: Voriconazole for IPA in Chinese Patients With COPD
Official title: Efficacy and Safety of Voriconazole for Treatment of Invasive Pulmonary Aspergillosis Secondary to COPD: a Multi-center Prospective，Open Cohort Study (VIA-COPD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Invasive Pulmonary Aspergillosis
COPD
Keywords: voriconazole
COPD
invasive pulmonary aspergillosis
efficacy
safety
Lead sponsor: Red Cross Hospital, Hangzhou, China
Sponsor class: OTHER
Collaborators: name: Sir Run Run Shaw Hospital
name: Zhejiang Provincial People's Hospital
name: First People's Hospital of Hangzhou
name: Second People's Hospital of Hangzhou
name: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: Ningbo People's Hospital
name: Xiaoshan People's Hospital
name: Xiaoshan Hospital
name: The First People's Hospital of Huzhou
First posted: 2014-09-09
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: success rate of voriconazole antifungal treatment
timeFrame: 2-week
Secondary outcomes:
measure: adverse reactions following voriconazole treatment
timeFrame: 2-week
Other outcomes:
measure: all-cause mortality of invasive pulmonary aspergillosis secondary to COPD
timeFrame: 2 week
Locations:
city: Hangzhou
country: China
facility: Hangzhou Red Cross Hospital
state: Zhejiang
Study officials:
affiliation: Red Cross Hospital, Hangzhou, China
name: Chuang Cai, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tutar N, Metan G, Koc AN, Yilmaz I, Bozkurt I, Simsek ZO, Buyukoglan H, Kanbay A, Oymak FS, Gulmez I, Demir R. Invasive pulmonary aspergillosis in patients with chronic obstructive pulmonary disease. Multidiscip Respir Med. 2013 Sep 4;8(1):59. doi: 10.1186/2049-6958-8-59. eCollection 2013.
citation: Patel DA, Gao X, Stephens JM, Forshag MS, Tarallo M. US hospital database analysis of invasive aspergillosis in the chronic obstructive pulmonary disease non-traditional host. J Med Econ. 2011;14(2):227-37. doi: 10.3111/13696998.2011.564246. Epub 2011 Mar 9.
citation: Ader F, Bienvenu AL, Rammaert B, Nseir S. Management of invasive aspergillosis in patients with COPD: rational use of voriconazole. Int J Chron Obstruct Pulmon Dis. 2009;4:279-87. doi: 10.2147/copd.s4229. Epub 2009 Aug 3.
citation: Walsh TJ, Anaissie EJ, Denning DW, Herbrecht R, Kontoyiannis DP, Marr KA, Morrison VA, Segal BH, Steinbach WJ, Stevens DA, van Burik JA, Wingard JR, Patterson TF; Infectious Diseases Society of America. Treatment of aspergillosis: clinical practice guidelines of the Infectious Diseases Society of America. Clin Infect Dis. 2008 Feb 1;46(3):327-60. doi: 10.1086/525258. No abstract available.