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Voriconazole as Prophylactic Therapy in Lung Transplant Recipients

Assessment of Safety and Efficacy of Voriconazole as Prophylactic Antifungal Therapy for Lung Transplant Recipients

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00455364
Acronym
VORI
Enrollment
20
Registered
2007-04-03
Start date
2007-04-30
Completion date
2007-04-30
Last updated
2013-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

Keywords

Fungal infection prophylaxis, Lung transplant, Fungal infection post lung transplant

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

Interventions

DRUGVoriconazole

Sponsors

Pfizer
CollaboratorINDUSTRY
University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Subject will be monitored for any fungal infection throughout the duration of the study.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026