Official Title: “Assessment of Safety and Efficacy of Voriconazole as Prophylactic Antifungal Therapy for Lung Transplant Recipients”

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

Study Type: Interventional

Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Intervention(s) in this Clinical Trial

• Drug: Voriconazole

Primary Measures

• Subject will be monitored for any fungal infection throughout the duration of the study.

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Chicago

Overall Clinical Trial Officials and Contacts

Sangeeta Bhorade, MD Principal Investigator University of Chicago  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00455364

Study ID Number: 14559A

ClinicalTrials.gov Identifier: NCT00455364

Health Authority: United States: Institutional Review Board