Voriconazole for IPA in Chinese Patients With COPD

COPD Clinical Trial

— VIA-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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02234739
• Other study ID #: Hangzhou Red Cross Hospital
• Status: Not yet recruiting
• Phase: Phase 4
• First received: September 2, 2014
• Last updated: September 8, 2014
• Start date: October 2014
• Est. completion date: December 2016

Study information

• Verified date: September 2014
• Source: Red Cross Hospital, Hangzhou, China
• Contact: Chuang Cai, doctor
• Phone: 86-0571-56109772
• Email: tinattm[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aspergillosis
• COPD
• Invasive Pulmonary Aspergillosis
• Pulmonary Aspergillosis

Intervention

Drug:
• Voriconazole
2-week long intravenous instillation of voriconazole

Locations

Country	Name	City	State
China	Hangzhou Red Cross Hospital	Hangzhou	Zhejiang

Sponsors (10)

Lead Sponsor	Collaborator
Red Cross Hospital, Hangzhou, China	First People's Hospital Affiliated to Huzhou University, First People's Hospital of Hangzhou, Hangzhou Hospital of Traditional Chinese Medicine, Ningbo People's Hospital, Second People's Hospital of Hangzhou, Sir Run Run Shaw Hospital, Xiaoshan Hospital, Xiaoshan People's Hospital, Zhejiang Provincial People’s Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. Epub 2009 Aug 3. Review. — View 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. — View Citation

Tutar N, Metan G, Koç 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	all-cause mortality of invasive pulmonary aspergillosis secondary to COPD	all-cause mortality	2 week	No
Primary	success rate of voriconazole antifungal treatment	treatment success if defined as improve of symptoms related to invasive pulmonary aspergillosis, such as fever, wheezing, chest pain, dyspnea, and hemoptysis	2-week	Yes
Secondary	adverse reactions following voriconazole treatment	any adverse events including complaints, physical signs, or laboratory abnormalities	2-week	Yes