VORI: Voriconazole as Prophylactic Therapy in Lung Transplant Recipients

• Sponsor: University of Chicago (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00455364
• Collaborator: Pfizer (Industry)
• Enrollment: 20
• Location: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Infection	Drug: Voriconazole	Phase 4

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Assessment of Safety and Efficacy of Voriconazole as Prophylactic Antifungal Therapy for Lung Transplant Recipients
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Apr 1, 2007
• Actual Study Completion Date: Apr 1, 2007

Outcome Measures

Primary Outcome Measures

1. Subject will be monitored for any fungal infection throughout the duration of the study. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Chicago	Chicago	Illinois	United States	60637

Sponsors and Collaborators

• University of Chicago
• Pfizer

Investigators

• Principal Investigator: Sangeeta Bhorade, MD, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Chicago
• ClinicalTrials.gov Identifier: NCT00455364
• Other Study ID Numbers: 14559A
• First Posted: Apr 3, 2007
• Last Update Posted: Feb 6, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by University of Chicago: Fungal infection prophylaxis; Lung transplant; Fungal infection post lung transplant
• Additional relevant MeSH terms: Infections; Voriconazole

Study Results

No Results Posted as of Feb 6, 2013