Voriconazole as Prophylactic Therapy in Lung Transplant Recipients
The purpose of this study is to compare the safety and efficacy of Voriconazole with Itraconazole following lung transplantation...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
- Study Primary Completion Date: April 2007
Detailed Clinical Trial 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
Intervention(s) in this Clinical Trial
- Drug: Voriconazole
Outcome Measures for this Clinical Trial
Primary Measures
- Subject will be monitored for any fungal infection throughout the duration of the study.
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: University of Chicago Other
Overall Clinical Trial Officials and Contacts
Sangeeta Bhorade, MD Principal Investigator University of Chicago
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00455364
