NCT00455364

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2007

Completed
Last Updated

February 6, 2013

Status Verified

February 1, 2013

Enrollment Period

Same day

First QC Date

April 2, 2007

Last Update Submit

February 5, 2013

Conditions

Infection

Keywords

Fungal infection prophylaxisLung transplantFungal infection post lung transplant

Outcome Measures

Primary Outcomes (1)

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

Interventions

VoriconazoleDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Lung transplant patients unable to give informed consent.
  • Prior adverse reaction to the drug itraconazole or voriconazole

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Infections

Interventions

Voriconazole

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Sangeeta Bhorade, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2007

First Posted

April 3, 2007

Study Start

April 1, 2007

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

February 6, 2013

Record last verified: 2013-02

Locations

US(1)