Post Lung TransplantationNCT00177827
Voriconazole Prophylaxis Against Aspergillosis in Lung Transplant Recipients
An observational study of Post Lung Transplantation, run by University of Pittsburgh at 1 site in United States.
Trial summary
A fixed dosage regimen of voriconazole is routinely used for prophylaxis of aspergillosis in lung transplant patients at our institution. We hypothesize that use of a fixed dosage voriconazole regimen leads to large degree of variability in drug exposure among lung transplant patients and consequently, therapeutic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Lung Transplantation
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Mar 2006
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chart review
Who may be able to join
- Male or female lung transplant recipients, greater than 18 years old, who are initiated on the voriconazole prophylactic regimen (Figure 1) by their transplant physician as standard care will be eligible for inclusion in the study.
Who cannot join
- Patients receiving voriconazole to treat an active fungal infection will be excluded. Patients that are concurrently receiving medications that are documented to affect voriconazole pharmacokinetics will be excluded. The agents included, but may not be limited to the following ;carbamazepine, phenytoin, omeprazole, rifabutin and rifampin.10
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Voriconazole Prophylaxis Against Aspergillosis in Lung Transplant Recipients: Pharmacokinetics and Correlation Between Plasma and Lung Concentrations With Toxicity/Efficacy
A fixed dosage regimen of voriconazole is routinely used for prophylaxis of aspergillosis in lung transplant patients at our institution. We hypothesize that use of a fixed dosage voriconazole regimen leads to large degree of variability in drug exposure among lung transplant patients and consequently, therapeutic failures or toxicity. This is a three part study which will examine plasma and lung voriconazole concentrations achieved with the prophylactic regimen and assess for a correlation between these concentrations with efficacy and toxicity. We aim to conduct an initial pilot study in 12 lung transplant patients to characterize the pharmacokinetic profile of voriconazole with both intravenous and oral doses. The data gathered from the pilot pharmacokinetic study will then be utilized to correlate trough concentrations with total voriconazole drug exposure as measured by area under the plasma concentration versus time curve (AUC). Additionally, trough concentrations will be followed over nine weeks of the prophylactic treatment period in a larger cohort of patients to determine maintenance of consistency in trough concentrations and whether the plasma concentrations are predictive of efficacy and toxicity. Voriconazole lung concentrations will be measured in a pilot study of 12 patients who undergo a bronchoscopy procedure as part of their standard medical care in order to determine the relationship between plasma and lung concentrations. The information obtained from this three phase study will be utilized to characterize the pharmacokinetics of voriconazole in lung transplant patients. Further, it will be used to define an optimal therapeutic voriconazole regimen that will be individualized to target specific concentrations in the lung and plasma to maximize efficacy and minimize toxicity
Read the detailed description
Blood samples (5 mL) will be collected either from an existing indwelling intravenous catheter or via a catheter placed by a research nurse or phlebotomist. The samples will be centrifuged at 1,500 g for 10 minutes within 60 minutes of collection. The plasma will be separated into two separate cryovials and stored at - 80 C until the time of assay for Voriconazole.A standardized data collection sheet will be created by the study investigators and utilized to gather pertinent information on each study participant from the patient medical records and electronic databases. The type of information collected will include, but will not be limited to, demographic information, transplant history, periodic serum chemistry and hematology monitoring, medication regimen, plasma voriconazole level monitoring and efficacy and safety monitoring parameters.
- Conditions
- Post Lung Transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMar 2004
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Lung TransplantationStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 104 participants
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Investigators
- Blair Capitano, Pharm D, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00177827
- Sponsor's protocol ID
- IRB# 0304017
- Status last verified
- Dec 2009
- First submitted
- 13 Sep 2005
- Last updated
- 3 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voriconazole Prophylaxis Against Aspergillosis in Lung Transplant Recipients: Pharmacokinetics and Correlation Between Plasma and Lung Concentrations With Toxicity/Efficacy
- ClinicalTrials.gov ID
- NCT00177827
- Acronym / sponsor ID
- IRB# 0304017
- Conditions
- Post Lung Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- Mar 2004
- Study completion
- Mar 2006 (actual)
- First posted
- 15 Sep 2005 (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.
A fixed dosage regimen of voriconazole is routinely used for prophylaxis of aspergillosis in lung transplant patients at our institution. We hypothesize that use of a fixed dosage voriconazole regimen leads to large degree of variability in drug exposure among lung transplant patients and consequently, therapeutic failures or toxicity. This is a three part study which will examine plasma and lung voriconazole concentrations achieved with the prophylactic regimen and assess for a correlation between these concentrations with efficacy and toxicity. We aim to conduct an initial pilot study in 12 lung transplant patients to characterize the pharmacokinetic profile of voriconazole with both intravenous and oral doses. The data gathered from the pilot pharmacokinetic study will then be utilized to correlate trough concentrations with total voriconazole drug exposure as measured by area under the plasma concentration versus time curve (AUC). Additionally, trough concentrations will be followed over nine weeks of the prophylactic treatment period in a larger cohort of patients to determine maintenance of consistency in trough concentrations and whether the plasma concentrations are predictive of efficacy and toxicity. Voriconazole lung concentrations will be measured in a pilot study of 12 patients who undergo a bronchoscopy procedure as part of their standard medical care in order to determine the relationship between plasma and lung concentrations. The information obtained from this three phase study will be utilized to characterize the pharmacokinetics of voriconazole in lung transplant patients. Further, it will be used to define an optimal therapeutic voriconazole regimen that will be individualized to target specific concentrations in the lung and plasma to maximize efficacy and minimize toxicity
Detailed description
Blood samples (5 mL) will be collected either from an existing indwelling intravenous catheter or via a catheter placed by a research nurse or phlebotomist. The samples will be centrifuged at 1,500 g for 10 minutes within 60 minutes of collection. The plasma will be separated into two separate cryovials and stored at - 80 C until the time of assay for Voriconazole.A standardized data collection sheet will be created by the study investigators and utilized to gather pertinent information on each study participant from the patient medical records and electronic databases. The type of information collected will include, but will not be limited to, demographic information, transplant history, periodic serum chemistry and hematology monitoring, medication regimen, plasma voriconazole level monitoring and efficacy and safety monitoring parameters.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chart review
Key inclusion criteria (1 listed)
- Male or female lung transplant recipients, greater than 18 years old, who are initiated on the voriconazole prophylactic regimen (Figure 1) by their transplant physician as standard care will be eligible for inclusion in the study.
Key exclusion criteria (1 listed)
- Patients receiving voriconazole to treat an active fungal infection will be excluded. Patients that are concurrently receiving medications that are documented to affect voriconazole pharmacokinetics will be excluded. The agents included, but may not be limited to the following ;carbamazepine, phenytoin, omeprazole, rifabutin and rifampin.10
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2009.
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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.
Blair Capitano, Pharm D principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Lung Transplantation, run by University of Pittsburgh 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 Dec 2009. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 3 Dec 2009.