Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care (PTN_POPS)
This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Duke University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The EMMES Corporation
Information provided by (Responsible Party):
Daniel Benjamin, Duke University Medical Center
First received: August 17, 2011
Last updated: February 27, 2015
Last verified: February 2015
No Study Results Posted on ClinicalTrials.gov for this Study
|Study Status:||This study is currently recruiting participants.|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Phan H, Leder M, Fishley M, Moeller M, Nahata M. Off-label and unlicensed medication use and associated adverse drug events in a pediatric emergency department. Pediatr Emerg Care. 2010 Jun;26(6):424-30. doi: 10.1097/PEC.0b013e3181e057e1.
Shah SS, Hall M, Goodman DM, Feuer P, Sharma V, Fargason C Jr, Hyman D, Jenkins K, White ML, Levy FH, Levin JE, Bertoch D, Slonim AD. Off-label drug use in hospitalized children. Arch Pediatr Adolesc Med. 2007 Mar;161(3):282-90. Erratum in: Arch Pediatr Adolesc Med. 2007 Jul;161(7):655.
de Hoog M, Schoemaker RC, Mouton JW, van den Anker JN. Vancomycin population pharmacokinetics in neonates. Clin Pharmacol Ther. 2000 Apr;67(4):360-7.
García B, Barcia E, Pérez F, Molina IT. Population pharmacokinetics of gentamicin in premature newborns. J Antimicrob Chemother. 2006 Aug;58(2):372-9. Epub 2006 Jun 16.
Wade KC, Wu D, Kaufman DA, Ward RM, Benjamin DK Jr, Sullivan JE, Ramey N, Jayaraman B, Hoppu K, Adamson PC, Gastonguay MR, Barrett JS; National Institute of Child Health and Development Pediatric Pharmacology Research Unit Network. Population pharmacokinetics of fluconazole in young infants. Antimicrob Agents Chemother. 2008 Nov;52(11):4043-9. doi: 10.1128/AAC.00569-08. Epub 2008 Sep 22.
Capparelli E, Hochwald C, Rasmussen M, Parham A, Bradley J, Moya F. Population pharmacokinetics of cefepime in the neonate. Antimicrob Agents Chemother. 2005 Jul;49(7):2760-6.
Spooner N, Lad R, Barfield M. Dried blood spots as a sample collection technique for the determination of pharmacokinetics in clinical studies: considerations for the validation of a quantitative bioanalytical method. Anal Chem. 2009 Feb 15;81(4):1557-63. doi: 10.1021/ac8022839.
Cheung CY, van der Heijden J, Hoogtanders K, Christiaans M, Liu YL, Chan YH, Choi KS, van de Plas A, Shek CC, Chau KF, Li CS, van Hooff J, Stolk L. Dried blood spot measurement: application in tacrolimus monitoring using limited sampling strategy and abbreviated AUC estimation. Transpl Int. 2008 Feb;21(2):140-5. Epub 2007 Oct 17.
Allanson AL, Cotton MM, Tettey JN, Boyter AC. Determination of rifampicin in human plasma and blood spots by high performance liquid chromatography with UV detection: a potential method for therapeutic drug monitoring. J Pharm Biomed Anal. 2007 Aug 15;44(4):963-9. Epub 2007 Apr 19.
Hibberd SG, Alveyn C, Coombes EJ, Holgate ST. Acute and chronic pharmacokinetics of asymmetrical doses of slow release choline theophyllinate in asthma. Br J Clin Pharmacol. 1986 Sep;22(3):337-41.
Meyer DM, Jessen ME. Results of extracorporeal membrane oxygenation in children with sepsis. The Extracorporeal Life Support Organization. Ann Thorac Surg. 1997 Mar;63(3):756-61.
Green TP, Timmons OD, Fackler JC, Moler FW, Thompson AE, Sweeney MF. The impact of extracorporeal membrane oxygenation on survival in pediatric patients with acute respiratory failure. Pediatric Critical Care Study Group. Crit Care Med. 1996 Feb;24(2):323-9.
Cohen P, Collart L, Prober CG, Fischer AF, Blaschke TF. Gentamicin pharmacokinetics in neonates undergoing extracorporal membrane oxygenation. Pediatr Infect Dis J. 1990 Aug;9(8):562-6.
Amaker RD, DiPiro JT, Bhatia J. Pharmacokinetics of vancomycin in critically ill infants undergoing extracorporeal membrane oxygenation. Antimicrob Agents Chemother. 1996 May;40(5):1139-42.
Dagan O, Klein J, Bohn D, Koren G. Effects of extracorporeal membrane oxygenation on morphine pharmacokinetics in infants. Crit Care Med. 1994 Jul;22(7):1099-101.
Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55.
Srinivasan V, Nadkarni VM, Helfaer MA, Carey SM, Berg RA; American Heart Association National Registry of Cardiopulmonary Resuscitation Investigators. Childhood obesity and survival after in-hospital pediatric cardiopulmonary resuscitation. Pediatrics. 2010 Mar;125(3):e481-8. doi: 10.1542/peds.2009-1324. Epub 2010 Feb 22.
Winnike JH, Li Z, Wright FA, Macdonald JM, O'Connell TM, Watkins PB. Use of pharmaco-metabonomics for early prediction of acetaminophen-induced hepatotoxicity in humans. Clin Pharmacol Ther. 2010 Jul;88(1):45-51. doi: 10.1038/clpt.2009.240. Epub 2010 Feb 24.