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Trial record 1 of 1 for:    NCT00455364
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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

Tracking Information
First Submitted Date  ICMJE April 2, 2007
First Posted Date  ICMJE April 3, 2007
Last Update Posted Date February 6, 2013
Study Start Date  ICMJE April 2007
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2007)
Subject will be monitored for any fungal infection throughout the duration of the study.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Voriconazole as Prophylactic Therapy in Lung Transplant Recipients
Official Title  ICMJE Assessment of Safety and Efficacy of Voriconazole as Prophylactic Antifungal Therapy for Lung Transplant Recipients
Brief Summary The purpose of this study is to compare the safety and efficacy of Voriconazole with Itraconazole following lung transplantation.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Infection
Intervention  ICMJE Drug: Voriconazole
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: April 2, 2007)
20
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2007
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00455364
Other Study ID Numbers  ICMJE 14559A
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Sangeeta Bhorade, MD University of Chicago
PRS Account University of Chicago
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP