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Krzysztof S. Bankiewicz - One of the best experts on this subject based on the ideXlab platform.

  • image guided convection enhanced delivery of gdnf protein into monkey putamen
    NeuroImage, 2011
    Co-Authors: Francisco Gimenez, Piotr Hadaczek, John Bringas, John Forsayeth, Michal T Krauze, Francisco Valles, Nitasha Sharma, Krzysztof S. Bankiewicz
    Abstract:

    Abstract Recently, we developed an MRI-based method that enables tracking of parenchymal Infusions of therapeutic agents by inclusion of a contrast reagent in the infusate. We show that both liposomal Gadoteridol (GDL) and free Gadoteridol (Gd) can be used for MRI-monitored Infusions into the non-human primate (NHP) putamen to predict the distribution of GDNF protein after convection-enhanced delivery (CED). GDNF and both MRI tracers showed good co-distribution within the putamen and other brain regions. Although the CED Infusion technique can distribute GDNF protein over large brain regions, continuous administration of GDNF could cause undesired effects that could counteract the benefits of CED as demonstrated in this study when large volumes of GDNF were delivered that lead to GDNF leakage into CSF. These limitations can be addressed by employing an intermittent CED schedule that permits consistent target coverage without GDNF leakage into CSF or white matter. We present an approach intracranial GDNF Infusions that can be optimized by means of real-time monitoring via MRI. Adoption of this new standard, along with advanced, reflux-resistant cannulae, may permit reconsideration of direct GDNF Infusion into parenchyma as a clinical strategy, since previous clinical studies involving chronic Infusion of recombinant glial cell line-derived neurotrophic factor (GDNF) to the putamen for the treatment of Parkinson's disease have yielded mixed results, a state of affairs that may in part be attributed to suboptimal Infusion parameters.

  • Transduction of nonhuman primate brain with adeno-associated virus serotype 1: vector trafficking and immune response.
    Human Gene Therapy, 2008
    Co-Authors: Piotr Hadaczek, Hanna Mirek, Keith Munson, Phil Pivirotto, Jodi L. Mcbride, John Bringas, John Forsayeth, Beverly L Davidson, Krzysztof S. Bankiewicz
    Abstract:

    Abstract We used convection-enhanced delivery (CED) to characterize gene delivery mediated by adeno-associated virus type 1 (AAV1) by tracking expression of hrGFP (humanized green fluorescent protein from Renilla reniformis) into the striatum, basal forebrain, and corona radiata of monkey brain. Four cynomolgus monkeys received single Infusions into corona radiata, putamen, and caudate. The other group (n = 4) received Infusions into basal forebrain. Thirty days after Infusion animals were killed and their brains were processed for immunohistochemical evaluation. Volumetric analysis of GFP-positive brain areas was performed. AAV1-hrGFP Infusions resulted in approximately 550, 700, and 73 mm3 coverage after Infusion into corona radiata, striatum, and basal forebrain, respectively. Aside from targeted regions, other brain structures also showed GFP signal (internal and external globus pallidus, subthalamic nucleus), supporting the idea that AAV1 is actively trafficked to regions distal from the Infusion sit...

  • Transduction of nonhuman primate brain with adeno-associated virus serotype 1: vector trafficking and immune response.
    Human Gene Therapy, 2008
    Co-Authors: Piotr Hadaczek, Hanna Mirek, Keith Munson, Phil Pivirotto, Jodi L. Mcbride, John Bringas, John Forsayeth, Beverly L Davidson, Krzysztof S. Bankiewicz
    Abstract:

    Abstract We used convection-enhanced delivery (CED) to characterize gene delivery mediated by adeno-associated virus type 1 (AAV1) by tracking expression of hrGFP (humanized green fluorescent protein from Renilla reniformis) into the striatum, basal forebrain, and corona radiata of monkey brain. Four cynomolgus monkeys received single Infusions into corona radiata, putamen, and caudate. The other group (n = 4) received Infusions into basal forebrain. Thirty days after Infusion animals were killed and their brains were processed for immunohistochemical evaluation. Volumetric analysis of GFP-positive brain areas was performed. AAV1-hrGFP Infusions resulted in approximately 550, 700, and 73 mm3 coverage after Infusion into corona radiata, striatum, and basal forebrain, respectively. Aside from targeted regions, other brain structures also showed GFP signal (internal and external globus pallidus, subthalamic nucleus), supporting the idea that AAV1 is actively trafficked to regions distal from the Infusion sit...

David P Nicolau - One of the best experts on this subject based on the ideXlab platform.

  • optimizing bactericidal exposure for β lactams using prolonged and continuous Infusions in the pediatric population
    Pediatric Blood & Cancer, 2009
    Co-Authors: Joshua D Courter, Joseph Levente Kuti, Jennifer E Girotto, David P Nicolau
    Abstract:

    Background Administration of β-lactams via prolonged or continuous Infusion has been utilized in adults to optimize drug exposure and clinical outcomes. As children exhibit increased drug clearance, this may further the benefit of prolonged or continuous Infusions. This dosing approach was applied to several β-lactams commonly utilized in children. Procedure A variety of cefepime, ceftazidime, imipenem/cilastatin, meropenem, and piperacillin/tazobactam regimens using administration times of 0.5, 3, or 24 hr Infusions were simulated in populations of 2- and 12-year-old children using Monte Carlo techniques. The probability of target attainment (PTA) was calculated for each dosing regimen. Minimum inhibitory concentration (MIC) frequencies for Pseudomonas aeruginosa were obtained for two pediatric acute care institutions in order to calculate cumulative fractions of response (CFR). Results Standard 0.5 hr Infusions resulted in poor PTA for most study agents at their susceptibility breakpoint, whereas 3 hr Infusions markedly improved PTA for cefepime (79 to 100%), ceftazidime (80 to 100%), imipenem (41 to 91%), and meropenem (33 to 97%). Piperacillin/tazobactam could not achieve a PTA > 21% for any dosing regimen at its breakpoint, though large improvements were observed at lower MICs. Continuous Infusion regimens resulted in similar PTA results to the same dose administered as 3 hr Infusions. CFR values for all drugs at both institutions improved when 3 hr or continuous Infusions were employed. Conclusions Prolonged and continuous Infusion dosing strategies improved the likelihood of obtaining bactericidal targets for these β-lactams in a simulated pediatric population. Based on these data, pediatric studies employing these strategies are warranted. Pediatr Blood Cancer 2009;53:379–385. © 2009 Wiley-Liss, Inc.

  • optimal dosing of piperacillin tazobactam for the treatment of pseudomonas aeruginosa infections prolonged or continuous Infusion
    Pharmacotherapy, 2007
    Co-Authors: Christina A Sutherland, Joseph Levente Kuti, David P Nicolau
    Abstract:

    Study Objective. To compare conventional intermittent dosing regimens of piperacillin-tazobactam with prolonged and continuous Infusions to determine the optimal dosing scheme against a local Pseudomonas aeruginosa population. Design. Pharmacodynamic Monte Carlo simulation model. Data Source. Microbiologic data from 470 consecutive nonduplicate P. aeruginosa isolates collected from a single institution over 6 months in 2006. Patients. Five thousand simulated surgical patients and patients with neutropenia. Measurements and Main Results. We simulated serum concentration-time profiles at steady state for several piperacillin-tazobactam dosing regimens, including intermittent, prolonged, and continuous Infusions. The probability of achieving 50% free time above the MIC against 470 P. aeruginosa isolates was calculated. The cumulative fractions of response for the intermittent-Infusion regimens were 74.7% (3.375 g every 6 hrs), 79.9% (4.5 g every 6 hrs), and 85.6% (3.375 g every 4 hrs). For prolonged-Infusion regimens, the cumulative fractions of response were 83.3% (3.375 g every 8 hrs, 4-hr Infusion), 87.1% (4.5 g every 8 hrs, 4-hr Infusion), and 89.6% (4.5 g every 6 hrs, 3-hr Infusion). For continuous-Infusion regimens, the cumulative fractions of response were 82.3% (10.125 g), 86.5% (13.5 g), 89.2% (18 g), 90.0% (20.25 g), and 90.6% (22.5 g). Conclusion. Both prolonged- and continuous-Infusion strategies improved the pharmacodynamics of piperacillin-tazobactam over those of traditional 30-minute intermittent-Infusion regimens. Prolonged- and continuous-Infusion regimens that contained the same daily doses of piperacillin had similar likelihoods of bactericidal exposure. Thus, the selection of dosing strategy depends on the availability of intravenous access versus the convenience of once-daily administration.

  • The clinical and economic benefits of administering piperacillin-tazobactam by continuous Infusion.
    Intensive and Critical Care Nursing, 2005
    Co-Authors: Srividya Kotapati, Erika C. Geissler, Joseph Levente Kuti, Charles H. Nightingale, David P Nicolau
    Abstract:

    Summary β-Lactam antibiotics, such as piperacillin–tazobactam, are commonly administered frequently throughout the day as intermittent Infusions over a period of 30–60 min. However, increasing knowledge of how these antibiotics kill bacteria has made continuous Infusion a valuable option to achieve maximal clinical outcomes while consuming the least amount of institutional resources. Continuous Infusion of piperacillin–tazobactam is currently used at our hospital because of its clinical and economic benefits when compared with intermittent Infusion. This article will review our experience with the administration of piperacillin–tazobactam by continuous Infusion and the numerous advantages we have documented. Additionally, advantages related to a reduction in nursing resource consumption will be a focus of discussion.

Piotr Hadaczek - One of the best experts on this subject based on the ideXlab platform.

  • image guided convection enhanced delivery of gdnf protein into monkey putamen
    NeuroImage, 2011
    Co-Authors: Francisco Gimenez, Piotr Hadaczek, John Bringas, John Forsayeth, Michal T Krauze, Francisco Valles, Nitasha Sharma, Krzysztof S. Bankiewicz
    Abstract:

    Abstract Recently, we developed an MRI-based method that enables tracking of parenchymal Infusions of therapeutic agents by inclusion of a contrast reagent in the infusate. We show that both liposomal Gadoteridol (GDL) and free Gadoteridol (Gd) can be used for MRI-monitored Infusions into the non-human primate (NHP) putamen to predict the distribution of GDNF protein after convection-enhanced delivery (CED). GDNF and both MRI tracers showed good co-distribution within the putamen and other brain regions. Although the CED Infusion technique can distribute GDNF protein over large brain regions, continuous administration of GDNF could cause undesired effects that could counteract the benefits of CED as demonstrated in this study when large volumes of GDNF were delivered that lead to GDNF leakage into CSF. These limitations can be addressed by employing an intermittent CED schedule that permits consistent target coverage without GDNF leakage into CSF or white matter. We present an approach intracranial GDNF Infusions that can be optimized by means of real-time monitoring via MRI. Adoption of this new standard, along with advanced, reflux-resistant cannulae, may permit reconsideration of direct GDNF Infusion into parenchyma as a clinical strategy, since previous clinical studies involving chronic Infusion of recombinant glial cell line-derived neurotrophic factor (GDNF) to the putamen for the treatment of Parkinson's disease have yielded mixed results, a state of affairs that may in part be attributed to suboptimal Infusion parameters.

  • Transduction of nonhuman primate brain with adeno-associated virus serotype 1: vector trafficking and immune response.
    Human Gene Therapy, 2008
    Co-Authors: Piotr Hadaczek, Hanna Mirek, Keith Munson, Phil Pivirotto, Jodi L. Mcbride, John Bringas, John Forsayeth, Beverly L Davidson, Krzysztof S. Bankiewicz
    Abstract:

    Abstract We used convection-enhanced delivery (CED) to characterize gene delivery mediated by adeno-associated virus type 1 (AAV1) by tracking expression of hrGFP (humanized green fluorescent protein from Renilla reniformis) into the striatum, basal forebrain, and corona radiata of monkey brain. Four cynomolgus monkeys received single Infusions into corona radiata, putamen, and caudate. The other group (n = 4) received Infusions into basal forebrain. Thirty days after Infusion animals were killed and their brains were processed for immunohistochemical evaluation. Volumetric analysis of GFP-positive brain areas was performed. AAV1-hrGFP Infusions resulted in approximately 550, 700, and 73 mm3 coverage after Infusion into corona radiata, striatum, and basal forebrain, respectively. Aside from targeted regions, other brain structures also showed GFP signal (internal and external globus pallidus, subthalamic nucleus), supporting the idea that AAV1 is actively trafficked to regions distal from the Infusion sit...

  • Transduction of nonhuman primate brain with adeno-associated virus serotype 1: vector trafficking and immune response.
    Human Gene Therapy, 2008
    Co-Authors: Piotr Hadaczek, Hanna Mirek, Keith Munson, Phil Pivirotto, Jodi L. Mcbride, John Bringas, John Forsayeth, Beverly L Davidson, Krzysztof S. Bankiewicz
    Abstract:

    Abstract We used convection-enhanced delivery (CED) to characterize gene delivery mediated by adeno-associated virus type 1 (AAV1) by tracking expression of hrGFP (humanized green fluorescent protein from Renilla reniformis) into the striatum, basal forebrain, and corona radiata of monkey brain. Four cynomolgus monkeys received single Infusions into corona radiata, putamen, and caudate. The other group (n = 4) received Infusions into basal forebrain. Thirty days after Infusion animals were killed and their brains were processed for immunohistochemical evaluation. Volumetric analysis of GFP-positive brain areas was performed. AAV1-hrGFP Infusions resulted in approximately 550, 700, and 73 mm3 coverage after Infusion into corona radiata, striatum, and basal forebrain, respectively. Aside from targeted regions, other brain structures also showed GFP signal (internal and external globus pallidus, subthalamic nucleus), supporting the idea that AAV1 is actively trafficked to regions distal from the Infusion sit...

Laurent Peyrin-biroulet - One of the best experts on this subject based on the ideXlab platform.

  • Tolerability of one hour 10mg/kg infliximab Infusions in inflammatory bowel diseases: A prospective multicenter cohort study
    Journal of Crohn's and Colitis, 2014
    Co-Authors: Abdenour Babouri, Xavier Roblin, Jérome Filippi, Xavier Hébuterne, Marc-andré Bigard, Laurent Peyrin-biroulet
    Abstract:

    Background and Aim In patients with inflammatory bowel disease (IBD) tolerating 2-h Infusions of 5 mg/kg infliximab scheduled maintenance therapy, the Infusion time can be shortened to 1-h with good tolerability. A retrospective study with small sample size demonstrated the feasibility of 1-hour Infusion time for 10 mg/kg infliximab in IBD patients. Methods Between November 2011 and July 2012, 63 patients received 1-hour 10 mg/kg infliximab Infusions under standard operating procedures and were enrolled in a prospective observational study. Intravenous steroid premedication was given to all patients. Results Sixty-three IBD patients on infliximab maintenance therapy (43 Crohn's disease, 34 males) received 1-hour 10 mg/kg Infusions during the study period. A total of 182 infliximab Infusions were administered. Seventeen (26%) patients were receiving concomitant immunomodulators. Two patients experienced (2/182, 1%) severe acute Infusion reactions consisting on a cutaneous lupus and one severe anaphylactic reaction. We also observed one (1/182, 0.5%) severe delayed reaction after the first 1-hour infliximab Infusion consisting on acne generalis. All 3 reactions led to infliximab discontinuation. No mild acute reactions and 6 mild delayed reactions (6/182, 3%) occurred. Conclusions In patients with IBD receiving infliximab scheduled maintenance therapy, 1-hour Infusion time for 10 mg/kg infliximab seems to be well tolerated. This option might be considered in clinical practice in order to decrease the extra-burden of infliximab Infusions in this patient population.

  • The Extra Burden of Infliximab Infusions in Inflammatory Bowel Disease
    Inflammatory Bowel Diseases, 2013
    Co-Authors: Anthony Buisson, Marc-andré Bigard, Anne-laure Seigne, Marie-caroline Dʼhuart, Laurent Peyrin-biroulet
    Abstract:

    Background Infliximab (IFX) Infusions require repeated hospitalizations. The median duration of each hospitalization stay, including time for Infusion and the cost for the health care system, are unknown. We assessed the extra burden of IFX Infusions in inflammatory bowel disease (IBD). Methods This was a prospective cross-sectional study enrolling all consecutive patients with IBD treated with IFX at the Nancy IBD Unit (January to March 2012). Four parameters were assessed: median travel duration, median time that patients stayed at the IBD unit, reimbursement for transport by the health care system, and impact of IFX Infusions on their work. Results Among 137 IBD patients, 48.9% were women, 74.5% had Crohn's disease, and the median age was 35 (range, 18–65) years. The median travel duration backward and forward from home to the Nancy IBD unit was 2 (range, 0.5–4) hours. The patients stayed at the IBD unit for a median period of 4.5 (range, 2.8–6.7) hours. For 63.5% of the patients (87/137), transport was reimbursed by the health care system. Of the patients receiving IFX Infusions, 10.9% (15/137) were unemployed, 24.8% (34/137) had the agreement of their employer to spend 1 day at the hospital for their IFX Infusion, 27.0% (36/137) asked specifically a vacation for the IFX Infusion, and 13.9% (19/137) were in sick leave. Conclusions The patients spend a median of 6.5 hours outside their home for each IFX Infusion, and they often take a day of vacation or rest. This represents an extra burden for IFX-treated patients and for the health care system.

Uno Erikson - One of the best experts on this subject based on the ideXlab platform.

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