Voriconazole as Prophylactic Therapy in Lung Transplant Recipients

Infection Clinical Trial

— VORI  

Official title:

Assessment of Safety and Efficacy of Voriconazole as Prophylactic Antifungal Therapy for Lung Transplant Recipients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00455364
• Other study ID #: 14559A
• Status: Terminated
• Phase: Phase 4
• First received: April 2, 2007
• Last updated: February 5, 2013
• Start date: April 2007
• Est. completion date: April 2007

Study information

• Verified date: February 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the safety and efficacy of Voriconazole with Itraconazole following lung transplantation.

Description:

All participants will receive itraconazole during their inpatient post transplant stay. As an outpatient, ten subjects will be randomized to receive itraconazole 200mg orally once daily for 6 month and ten patients to receive voriconazole 200mg orally twice daily for 6 months . All subjects will be followed in the clinic as per the standard transplant treatment

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Bilateral-lung or single-lung transplant recipients between the ages of 18- 65 years old.

• Patients must be able to give informed consent prior to and again after transplantation

Exclusion Criteria:

• Lung transplant patients unable to give informed consent.

• Prior adverse reaction to the drug itraconazole or voriconazole

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection

Intervention

Drug:
• Voriconazole

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject will be monitored for any fungal infection throughout the duration of the study.