PTN meropenem study published in the Federal Register

The PTN marks another milestone as the Food and Drug Administration (FDA) has published a summary report of its pediatric study of meropenem in the Federal Register.

Meropenem is a broad-spectrum anti-microbial drug often used to treat intra-abdominal infections in infants. The purpose of the PTN study, which began in the summer of 2008, was to determine the optimal dosing regimen for meropenem in infants younger than 90 days old. Researchers were also interested in determining how safe the drug is for very young infants, especially when compared with imipenem, another broad-spectrum anti-microbial drug closely related to meropenem.

The trial included 200 infants at 24 neonatal intensive care units across the United States. Findings suggested that meropenem as dosed in the study is a safe alternative for young infants with intra-abdominal infections. The FDA recently changed the label for meropenem to reflect these findings, which were published in the Pediatric Infectious Disease Journal.

In accordance with the Public Health Service Act, the FDA is making available the labeling changes for meropenem in the Federal Register.

Mercy TAPE moves closer to market

The FDA has approved the 510(k) application for the Mercy TAPE—an anthropometric-based device developed by Dr. Susan Abdel-Rahman at Children’s Mercy Hospital in Kansas City that predicts weight in children 2 months through 16 years of age. The results from the PTN study validating this device appeared in the Annals of Emergency Medicine in 2013.

Section 510(k) of the Food, Drug, and Cosmetic Act requires device manufacturers to notify the FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification—also called PMN or 510(k). This step allows the FDA to review the scientific evidence generated related to safety and efficacy and determine whether the device is equivalent to an existing device. Because the Mercy TAPE is the first weight estimation device to be submitted to the FDA, the agency examined it against a standard medical scale and subsequently generated a brand new product code to classify such devices.

The 501(k) approval clears the way for the Mercy TAPE to be marketed and distributed once the commercial partner registers with the FDA. In the meantime, the ongoing Baby TAPE study is collecting the necessary anthropometric data on children under the age of 3 months, with the eventual goal of developing, designing, and validating a similar weight estimation tool for newborns and young infants. Results from this study are expected in 2016.

PTN hosts an investigator gathering at PAS 2015

The PTN hosted an informational, informal gathering during the Pediatric Academic Society meeting in San Diego in late April, giving investigators and study personnel a chance to meet face to face. Thanks to all who participated!

From left to right: Jamie Gao (Duke), Adrienne Tremoulet (UCSD), Micky Cohen-Wolkowiez (Duke), Kristy Rica (University of Florida), Ashley Maddox (University of of Florida), Caroline Ludwig (Wake Forest University), Matt Laughon (UNC), Danny Gonzalez (UNC), Brian Smith (Duke), and Barrie Harper (Duke).
From left to right:
Jamie Gao (Duke), Adrienne Tremoulet (UCSD), Micky Cohen-Wolkowiez (Duke), Kristy Rica (University of Florida), Ashley Maddox (University of of Florida), Caroline Ludwig (Wake Forest University), Matt Laughon (UNC), Danny Gonzalez (UNC), Brian Smith (Duke), and Barrie Harper (Duke).

Baby TAPE activates first site

Penn State Milton S. Hershey Medical Center became the first site activated to enroll patients into the Baby TAPE study this week.

Weight is the foremost marker of health and health outcomes in infants. For infants receiving care in a neonatal intensive care unit, however, it can be nearly impossible to remove or account for the weight of life-sustaining medical equipment prior to obtaining a scale-based weight. The relative error introduced by such equipment can significantly affect the safety profile of the medicines these infants receive.

The Baby TAPE study will collect the necessary anthropometric data on children under the age of 3 months with the eventual goal of developing, designing, and validating a weight estimation tool for newborns and young infants. Anthropometric data on length and girth surrogates will be collected in 2000 infants at approximately 5–10 study sites.

PTN to present findings at PAS 2015

Researchers will be presenting results from PTN studies at the annual meeting of the Pediatric Academic Societies, to be held April 25-28, 2015, in San Diego. Presenters will include:

  • M. Smith et al., Pharmacokinetics of Multiple-Dose Intravenous Clindamycin in Obese Children (poster)
  • J. Momper et al., Population Pharmacokinetics of Fluconazole in Extremely Low Birth Weight Infants (platform)
  • J. Ericson et al., Effectiveness of G-CSF in hospitalized infants with neutropenia (poster)
  • J. Ericson et al., Safety of Acyclovir in Infants with HSV in the Era of High-dose Therapy (platform)
  • L. Ku et al., Safety of Enalapril in Young Infants (poster)

More details about the upcoming meeting may be found at the PAS website.