A Message from the Lead Principal Investigator
All of us at PTN are thankful for the dedication of our investigators, staff, and study participants and families. Because of their work and commitment, PTN’s studies have led to 7 FDA label changes for a variety of commonly used drugs in children. These changes will help health care providers determine the safest and most effective doses when treating our youngest patients. Please see below for information about our publications, studies, and other accomplishments over the past year.
In this issue, we also share the story of a 1-month-old patient at UNC Children’s Hospital who was successfully treated for a MRSA-related neck abscess using dosing recommendations for clindamycin that were based on findings from one of our studies. We also pay tribute to one of our dedicated investigators who will be retiring at the end of this year, Dr. Ram Yogev of Lurie Children’s Hospital in Chicago, and welcome his successor, Dr. William Muller.
If you have friends or colleagues who are interested in staying up-to-date on PTN's work, we encourage you to share this newsletter with them so they can subscribe . As always, thank you—your care and enthusiasm undergird the progress of this essential work.
Danny Benjamin, MD, PhD, MPH
The Year in Review
It has been a productive year for PTN. From September 2016 to September 2017, we submitted data to the FDA for a number of commonly used medications in infants and children. We also produced 7 articles for publication related to our studies. See below for a look back at the past year.

Final CSRs submitted to FDA:

  • Diazepam for seizure control to determine improved dosing
  • Doxycycline for treatment of common severe infections including tick-borne illnesses
  • Pantoprazole for treatment of gastroesophageal reflux disease (GERD) in obese children
  • Rifampin for treatment of complicated infections in neonates to determine safety and dosing
  • Sulfamethoxazole and trimethoprim for treatment of soft tissue infection to determine efficacy, safety, and dosing (in partnership with NIAID)

Draft CSRs submitted to FDA:

  • Caffeine citrate for treatment of apnea of prematurity to determine efficacy, safety, and dosing (in partnership with NHLBI)
  • Ondansetron for treatment of nausea and vomiting after chemotherapy or surgery in normal weight and obese children and adolescents


  • Pharmacokinetics of Clindamycin in Obese and Non‐obese Children. Smith MJ, Gonzalez D, Goldman JL, Yogev R, Sullivan JE, Reed MD, Anand R, Martz K, Berezny K, Benjamin DK, Smith PB, Cohen‐Wolkowiez M, Watt K; Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee. Antimicrobial Agents and Chemotherapy, March 2017

Study Contributes to Successful Treatment of MRSA Abscess
Early this summer, Lucas, a 1-month-old infant born 9 weeks prematurely, was receiving routine respiratory support in the neonatal intensive care unit at the University of North Carolina Children’s Hospital in Chapel Hill, N.C., when he suddenly developed a dangerous neck abscess. Upon testing, the infection was found to be caused by methicillin-resistant Staphylococcus aureus (MRSA) bacteria.

Dr. Jackie Patterson (pictured), who was caring for Lucas in the NICU, found an article published in the May 2016 issue of Antimicrobial Agents and Chemotherapy that reported results from a PTN trial on dosing for antibiotics including clindamycin in infants being treated for staph infections. After using the recommended dosing, Dr. Patterson saw dramatic improvement with no adverse effects. Lucas recovered completely by the end of the week-long treatment. Read more .
PTN Investigator to Retire at End of 2017
Dr. Ram Yogev (pictured center), PTN investigator and Director of the Section on Pediatric, Adolescent and Maternal HIV Infection at the Ann & Robert H. Lurie Children’s Hospital of Chicago, is retiring at the end of this year. For the past 5 years, Dr. Yogev has been an invaluable member of the PTN team. He was involved in several studies related to antibiotics, anti-epileptic drugs, and a measuring tape used to determine an infant’s weight when using a scale is impractical. He also enrolled the highest number of participants of any site in a 2012 trial assessing appropriate dosing for a variety of understudied drugs, and contributed more than 44,500 patient records to the PTN Data Repository, which will be used to inform the design of future PTN studies. Taking over Dr. Yogev’s role with PTN will be Dr. William Muller (pictured right), Attending Physician for Pediatric Infectious Diseases at Lurie Children’s. Read more .
PTN Determines Safe TMP/SMX Dosing for Children
The Pediatric Trials Network, with funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) , recently completed a multicenter study of trimethoprim/sulfamethoxazole (TMP/SMX) to determine appropriate dosing for infants and children. The results of the study were published in the journal Antimicrobial Agents and Chemotherapy on Oct. 30. Read more .