Back to resultsVoriconazole as Prophylactic Therapy in Lung Transplant Recipients (VORI)
Primary Purpose
Infection
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Voriconazole
Sponsored by
About this trial
This is an interventional prevention trial for Infection focused on measuring Fungal infection prophylaxis, Lung transplant, Fungal infection post lung transplant
Eligibility Criteria
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
Sites / Locations
- The University of Chicago
Outcomes
Primary Outcome Measures
Subject will be monitored for any fungal infection throughout the duration of the study.
Secondary Outcome Measures
Full Information
NCT ID
NCT00455364
First Posted
April 2, 2007
Last Updated
February 5, 2013
Sponsor
University of Chicago
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00455364
Brief Title
Voriconazole as Prophylactic Therapy in Lung Transplant Recipients
Acronym
VORI
Official Title
Assessment of Safety and Efficacy of Voriconazole as Prophylactic Antifungal Therapy for Lung Transplant Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
Protocol never received funding.
Study Start Date
April 2007 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the safety and efficacy of Voriconazole with Itraconazole following lung transplantation.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
Fungal infection prophylaxis, Lung transplant, Fungal infection post lung transplant
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Voriconazole
Primary Outcome Measure Information:
Title
Subject will be monitored for any fungal infection throughout the duration of the study.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sangeeta Bhorade, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Voriconazole as Prophylactic Therapy in Lung Transplant Recipients
We'll reach out to this number within 24 hrs