Advertisement

Topics

Voriconazole Prophylaxis Against Aspergillosis in Lung Transplant Recipients

2014-07-24 14:27:46 | BioPortfolio

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 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

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

Conditions

Post Lung Transplantation

Location

University of Pittsburgh Medical Center
Pittsburgh
Pennsylvania
United States
15213

Status

Completed

Source

University of Pittsburgh

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:27:46-0400

Clinical Trials [2024 Associated Clinical Trials listed on BioPortfolio]

Bayesian Dose Adjustment of Immunosuppressants After Lung Transplantation

The purpose of this study is to evaluate in lung or heart-lung transplant patients on tacrolimus and mycophenolate the impact of optimized mofetil (MMF) therapeutic drug monitoring and dos...

Effect of Early Pulmonary Rehabilitation After Lung Transplantation

The purpose of this observation study is to evaluate the effects of an early, 3 week lasting rehabilitation program, that starts roundabout 4 weeks after lung or combined lung transplantat...

Telecommunication Via Cell Phones During Post-Operative Treatment After Lung Transplantation

In an investigation should be evaluated in contrast to a control group with standard post-treatment therapy (using home spirometry) after lung transplantation if transfer of home spirometr...

QT-Prolongation in Lung Transplantation

Experimental intervention: electrocardiography. Control intervention: none Duration of intervention per patient/subject: 5 min, observation 6 months Key inclusion criteria: ...

Correlation of Lung Biopsy, BAL, and High Resolution CT Scan in Lung Transplantation

A major source of graft failure and dysfunction in lung transplantation is known to be bronchiolitis obliterans (BO)and its clinical correlate called bronchiolitis obliterans syndrome(BOS)...

PubMed Articles [10739 Associated PubMed Articles listed on BioPortfolio]

Acute Respiratory Failure Post Single Lung Transplantation: An Unusual Cause.

Vascular complications of pulmonary vessels post-transplant are rare but are associated with high morbidity and mortality. We describe the first published case of surgical management of pulmonary vein...

Selection of Candidates for Lung Transplantation and Controversial Issues.

Lung transplantation is a widely accepted treatment to manage the advanced stages of many lung diseases that have failed to respond to all other therapeutic interventions. There have been ever-expandi...

EXTRACORPOREAL PHOTOPHERESIS FOR BRONCHIOLITIS OBLITERANS SYNDROME AFTER LUNG TRANSPLANTATION.

Lung transplantation is a therapeutic option for select patients with end-stage lung disease. However, successful lung transplantation is hampered by chronic lung allograft dysfunction (CLAD), in part...

Inflammation and primary graft dysfunction after lung transplantation: CT-PET findings.

The leading cause of early mortality after lung transplantation is Primary Graft Dysfunction (PGD). We assessed the lung inflammation, inflation status and inhomogeneities after lung transplantation. ...

Causes, Preventability, and Cost of Unplanned Rehospitalizations Within 30 Days of Discharge Following Lung Transplantation.

Unplanned rehospitalizations (UR) within 30 days of discharge are common following lung transplantation. It is unknown whether UR represent preventable gaps in care or necessary interventions for comp...

Medical and Biotech [MESH] Definitions

Preparative treatment of transplant recipient with various conditioning regimens including radiation, immune sera, chemotherapy, and/or immunosuppressive agents, prior to transplantation. Transplantation conditioning is very common before bone marrow transplantation.

The transference of either one or both of the lungs from one human or animal to another.

Syndromes which feature DYSKINESIAS as a cardinal manifestation of the disease process. Included in this category are degenerative, hereditary, post-infectious, medication-induced, post-inflammatory, and post-traumatic conditions.

Transfer of HEMATOPOIETIC STEM CELLS from BONE MARROW or BLOOD between individuals within the same species (TRANSPLANTATION, HOMOLOGOUS) or transfer within the same individual (TRANSPLANTATION, AUTOLOGOUS). Hematopoietic stem cell transplantation has been used as an alternative to BONE MARROW TRANSPLANTATION in the treatment of a variety of neoplasms.

An organism that, as a result of transplantation of donor tissue or cells, consists of two or more cell lines descended from at least two zygotes. This state may result in the induction of donor-specific TRANSPLANTATION TOLERANCE.

More From BioPortfolio on "Voriconazole Prophylaxis Against Aspergillosis in Lung Transplant Recipients"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Pulmonary
Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza,  Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Transplantation
Organ transplantation is the moving of an organ from one body to another or from a donor site to another location on the patient's own body, for the purpose of replacing the recipient's damaged or absent organ. The emerging field of regenerative ...


Searches Linking to this Trial