Voriconazole as Prophylactic Therapy in Lung Transplant Recipients
NCT00455364
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
- 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
- Lung transplant patients unable to give informed consent.
- Prior adverse reaction to the drug itraconazole or voriconazole
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Descriptive Information | ||||
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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 | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |