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Voriconazole as Prophylactic Therapy in Lung Transplant Recipients (VORI)

This study has been terminated.
(Protocol never received funding.)
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00455364
First received: April 2, 2007
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Infection
 Drug: Voriconazole
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Assessment of Safety and Efficacy of Voriconazole as Prophylactic Antifungal Therapy for Lung Transplant Recipients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Subject will be monitored for any fungal infection throughout the duration of the study.

Estimated Enrollment: 20
Study Start Date: April 2007
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00455364

Locations
United States, Illinois
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
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00455364     History of Changes
Other Study ID Numbers: 14559A
Study First Received: April 2, 2007
Last Updated: February 5, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of Chicago:
Fungal infection prophylaxis
Lung transplant
Fungal infection post lung transplant

Additional relevant MeSH terms:
Voriconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013