Early this summer, Lucas,* a one-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 when he suddenly developed a dangerous neck abscess. Upon testing, the infection was found to be caused by methicillin-resistant Staphylococcus aureus (MRSA) bacteria. Staphylococcus infections in general can be life-threatening in the NICU, but because MRSA is resistant to many commonly used antibiotic therapies, Lucas’ treatment options were limited from the outset.
Neonatologist Jackie Patterson, who was caring for Lucas in the NICU, immediately turned to the medical literature to determine the best course of treatment. During her search, she found an article published in the May 2016 issue of Antimicrobial Agents and Chemotherapy that was directly relevant to Lucas’ case. The article reported results from a trial sponsored by the Pediatric Trials Network (PTN) that explored dosing for antibiotics including clindamycin in infants being treated for staph infections.
Clindamycin was originally approved by the FDA in 1997 and is used to treat bacterial infections when other antibiotics, including penicillin and methicillin, are ineffective. The PTN “Anti-Staph Trio” study, a multicenter trial that evaluated 3 different antibiotic therapies for staph infections, was designed to identify drug dosages appropriate for use in term and pre-term infants—information that was not available in existing product labeling.
By combining their findings with pharmacokinetic and safety data from two other studies, the authors were able to describe a dosing regimen for clindamycin in premature infants based on postmenstrual age and total body weight that would allow physicians to effectively treat the infection while avoiding unwanted side effects.
Dr. Patterson knew, based on lab results, that Lucas’ particular strain of MRSA was sensitive to clindamycin. Thanks to the data published in the PTN study, she was able to choose a dosing strategy that would be most effective for Lucas.
“After only a couple of days, we saw a dramatic improvement with no adverse effects,” she said. Lucas recovered completely by the end of the week-long treatment, and was discharged healthy later in the summer.
Although Lucas’s parents had initial concerns about the treatment, they were reassured when Dr. Patterson referenced the study.
“We were confident about our treatment because of the literature,” she said. “This made the family confident in us.”
However, Dr. Patterson noted that this is not always the case, pointing out that information to guide dosing for infants and premature neonates is often sorely lacking.
“In pediatrics, we’re often extrapolating from adult data,” Dr. Patterson said. “In part because families are reluctant to enroll their children in clinical trials, it’s hard to find data specifically related to infants and children.”
Bridging this gap is a key goal for the PTN, an alliance of more than 100 clinical research sites cooperating in the design and conduct of pediatric clinical trials. Sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the PTN works to improve healthcare for the youngest patients by providing much-needed information on optimal dosing of commonly used drugs.
“The work that PTN is doing is critical,” Dr. Patterson said. “Especially when working with life-threatening conditions in the newborn population, the more science behind our medical practices, the more confident we can be that we will deliver the best outcomes for our patients and their families.”
*Name has been changed to protect confidentiality.