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Voriconazole as Prophylactic Therapy in Lung Transplant Recipients (VORI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00455364
Recruitment Status : Terminated (Protocol never received funding.)
First Posted : April 3, 2007
Last Update Posted : February 6, 2013
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Chicago

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 Type : Interventional  (Clinical Trial)
Estimated 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 : April 2007
Primary Completion Date : April 2007
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00455364     History of Changes
Other Study ID Numbers: 14559A
First Posted: April 3, 2007    Key Record Dates
Last Update Posted: February 6, 2013
Last Verified: February 2013

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

Additional relevant MeSH terms:
Infection
Voriconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors