PTN News

  • The Institute of Medicine releases report on pediatric studies conducted under BPCA and PREA August 21, 2013 http://vimeo.com/38530244 The Institute of Medicine (IOM) released a report today that finds that federal laws motivating or requiring drugmakers to conduct pediatric studies have yielded important information to guide the use of medications in children. Titled “Safe and Effective Medicines for Children: Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity ...
  • PTN study of clindamycin dosing in obese children enrolls first patients August 20, 2013 The University of Louisville in Kentucky and Children’s Mercy Hospital of Kansas City, Missouri, have enrolled the first two patients into the PTN study of the safety and pharmacokinetics of clindamycin in obese children. Principal investigators Michael Smith, MD, (Louisville) and Jen Goldman, MD, (Children’s Mercy) both enrolled their participants on August 8, marking the ...
  • The Clinical Pharmacology Core of the PTN May 7, 2013 Greg Kearns, chair of the PTN Clinical Pharmacology Core, explains how clinical pharmacology helps to make medicines safer for children. http://vimeo.com/64577747
  • The fluconazole prophylaxis study locks its database April 8, 2013 The PTN team behind the Safety of Fluconazole Prophylaxis in Infants study successfully locked the Benjamin study database last week. To evaluate the safety of fluconazole, the team is gathering randomized trial datasets from several thought leaders to perform a data meta-analysis—the Benjamin study comprises the first of these datasets. The PTN will examine safety ...
  • A busy week for the PTN sildenafil trial February 26, 2013 The week of February 18–22 saw many milestones in the PTN sildenafil trial. On Tuesday, the first investigator’s meeting was held. By Wednesday, the trial’s first two sites had been activated — one at the Medical University of South Carolina Children’s Hospital (MUSC) and the other at the University of North Carolina–Chapel Hill. And, on ...
  • The PTN anti-staph trial marks its first enrollment February 12, 2013 Dr. Barry Bloom and Ms. Paula Delmore at Wesley Medical Center in Wichita, Kansas, have enrolled the first baby into the Pharmacokinetics of Anti-staphylococcal Antibiotics in Infants trial. The infant—born at 24 weeks gestation and now 52 days old—is receiving clindamycin, one of three anti-staphylococcal antibiotics routinely used in preemies to treat staphylococcal infections. Seventy percent ...
  • The POPS study grows by leaps and bounds February 1, 2013 The POPS study is moving full steam ahead. In September 2012, the study received additional funding from the National Institute of Child Health and Human Development to effectively double in size, increasing the number of patients enrolled from 500 to ~1000 and doubling the number of participating sites from ~15 to ~30. And the new year ...
  • The PTN provides insights and updates at the 2012 BPCA annual meeting December 14, 2012 On December 4, 2012, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) staged the 2012 Best Pharmaceuticals for Children Act (BPCA) Annual Meeting in Rockville, MD. This yearly event serves as part of the NICHD mandate to oversee a priority list of needs in pediatric therapeutics under the BPCA. The BPCA ...
  • PTN acyclovir trial locks its database November 29, 2012 On September 19, 2012, the PTN locked the database for its trial of the pharmacokinetics of acyclovir in infants. Database lock means that all clinical trial data have been reviewed, queries have been resolved and issues addressed, and the database cannot be altered in any way. Acyclovir is approved by the U.S. Food and Drug Administration ...
  • PTN Acyclovir Trial Completes Enrollment November 29, 2012 On June 1, 2012, the PTN completed enrollment into its trial of the pharmacokinetics of acyclovir in infants. Acyclovir is approved by the U.S. Food and Drug Administration for herpes simplex virus (HSV) infections in babies. HSV is a very serious infection in this vulnerable group, often resulting in death or profound mental retardation. To date, ...