Voriconazole as Prophylactic Therapy in Lung Transplant Recipients

NCT ID: NCT00455364

Last Updated: 2013-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-04-30

Brief Summary

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

Detailed Description

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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

Conditions

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Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Voriconazole

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sangeeta Bhorade, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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The University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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14559A

Identifier Type: -

Identifier Source: org_study_id

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