Voriconazole as Prophylactic Therapy in Lung Transplant Recipients (VORI)

The University of Chicago

Status and phase: Terminated; Phase 4

Conditions: Infection

Treatments: Drug: Voriconazole

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00455364

14559A

Details and patient eligibility

About

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

Full 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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)