This is an application for continuation of funding for the Cleveland Pediatric Pharmacology Research Unit (PPRU). Our unit was first funded in 1994, one year after the establishment of the PPRU and has been funded since then at a level one-half to two thirds that of the other units in the network. Despite this funding bias, Cleveland has been an active member of the Network. During the first four years we participated in 13 network protocols contributing 298 patients. The last five years have seen this trajectory in activity maintained. We have been the lead site on 28 protocols and participated overall in 69 network studies enrolling more than 657 children. We have also completed two major multisite studies designed and coordinated by the Cleveland PPRU that have subsequently been adopted by the drugs'innovators to support SNDA filings. In support of ongoing PPRU activities we have developed two print symposia, one dealing with the evaluation of antihypertensive agents in children and the other dealing with the treatment of sleep disorders in children, designed to set the stage for further clinical trials. Finally we are the lead site on the first PPRU-exclusive multisite R01 application submitted to NIH. Our renewal application both details our accomplishments as a member of the PPRU Network and outlines our plans to expand our research base into several new therapeutic areas. To compliment our demonstrated expertise in pharmacokinetic/ pharmacodynamic modeling we propose a study to evaluate new approaches to study design that should add parsimony to our efforts at pediatric drug development. These approaches will be essential in support of the upcoming PPRU initiatives in response to the Best Pharmaceuticals for Children Act. We will also bring to the network a series of trials in the area of pediatric sleep disorders. We will also present approaches to the integration of pharmacogenetic approaches into the elucidation of novel mechanisms of adverse drug reactions in children. Finally, we will discuss our expanded training program in pediatric pharmacology research.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
3U10HD031323-15S1
Application #
7867657
Study Section
Special Emphasis Panel (ZHD1-DSR-A (01))
Program Officer
Giacoia, George
Project Start
1994-09-29
Project End
2009-12-31
Budget Start
2008-01-01
Budget End
2009-12-31
Support Year
15
Fiscal Year
2009
Total Cost
$273,420
Indirect Cost
Name
Case Western Reserve University
Department
Pediatrics
Type
Schools of Medicine
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106
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Neely, Michael; Kaplan, Edward L; Blumer, Jeffrey L et al. (2014) A population pharmacokinetic modeling approach shows that serum penicillin G concentrations are below inhibitory concentrations by two weeks after benzathine penicillin G injection in the majority of young adults. Antimicrob Agents Chemother 58:6735-41
Redwine, Karen; Howard, Lee; Simpson, Pippa et al. (2012) Effect of placebo on ambulatory blood pressure monitoring in children. Pediatr Nephrol 27:1937-42
Zoltanski, Joan; Dul, Michael; O'Riordan, Mary Ann et al. (2011) Low frequency of endemic patient-to-patient transmission of antibiotic-resistant gram-negative bacilli in a pediatric intensive care unit. Infect Control Hosp Epidemiol 32:915-7
Endimiani, Andrea; Blackford, Martha; Dasenbrook, Elliot C et al. (2011) Emergence of linezolid-resistant Staphylococcus aureus after prolonged treatment of cystic fibrosis patients in Cleveland, Ohio. Antimicrob Agents Chemother 55:1684-92
Blumer, Jeffrey; Rodriguez, Adib; Sánchez, Pablo J et al. (2010) Single-dose pharmacokinetics of famciclovir in infants and population pharmacokinetic analysis in infants and children. Antimicrob Agents Chemother 54:2032-41
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Toltzis, Philip; Dul, Michael; O'Riordan, Mary Ann et al. (2009) Meropenem use and colonization by antibiotic-resistant Gram-negative bacilli in a pediatric intensive care unit. Pediatr Crit Care Med 10:49-54
Toltzis, Philip; Kim, Jason; Dul, Michael et al. (2009) Presence of the epidemic North American Pulsed Field type 1 Clostridium difficile strain in hospitalized children. J Pediatr 154:607-8
Blumer, J L; Reed, M D; Steinberg, F et al. (2008) Potential pharmacokinetic basis for zolpidem dosing in children with sleep difficulties. Clin Pharmacol Ther 83:551-8

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