InfectionPhase 4VORINCT00455364
Voriconazole as Prophylactic Therapy in Lung Transplant Recipients
A Phase 4 study testing Voriconazole in people with Infection, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to compare the safety and efficacy of Voriconazole with Itraconazole following lung transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Infection
- What is being tested?
- Voriconazole
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Apr 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Lung transplant patients unable to give informed consent.
- Prior adverse reaction to the drug itraconazole or voriconazole
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Safety and Efficacy of Voriconazole as Prophylactic Antifungal Therapy for Lung Transplant Recipients
The purpose of this study is to compare the safety and efficacy of Voriconazole with Itraconazole following lung transplantation.
Read the 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
- Conditions
- Infection
- Being tested
- Voriconazole
- Keywords
- Fungal infection prophylaxis, Lung transplant, Fungal infection post lung transplant
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VoriconazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject will be monitored for any fungal infection throughout the duration of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionApr 2007
- Study completionApr 2007
Why it stopped: Protocol never received funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Sangeeta Bhorade, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455364
- Sponsor's protocol ID
- 14559A
- Acronym
- VORI
- Status last verified
- Feb 2013
- First submitted
- 2 Apr 2007
- Last updated
- 6 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety and Efficacy of Voriconazole as Prophylactic Antifungal Therapy for Lung Transplant Recipients
- ClinicalTrials.gov ID
- NCT00455364
- Acronym / sponsor ID
- VORI / 14559A
- Conditions
- Infection
- Keywords
- Fungal infection prophylaxis, Lung transplant, Fungal infection post lung transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol never received funding.
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Apr 2007
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 3 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Lung transplant patients unable to give informed consent.
- Prior adverse reaction to the drug itraconazole or voriconazole
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voriconazole | Drug | – |
Primary outcome
Subject will be monitored for any fungal infection throughout the duration of the study.
Results and safety
The study was stopped early (reason given: Protocol never received funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sangeeta Bhorade, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Voriconazole in people with Infection, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Protocol never received funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject will be monitored for any fungal infection throughout the duration of the study.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2013; AzTrials last refreshed its copy on 7 Nov 2026.