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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Communicable Diseases
Infection
Voriconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014