Julia E. Szymczak, PhD, Leads $12M PCORI Trial on Pneumonia
The Patient-Centered Outcomes Research Institute (PCORI) has awarded Julia E. Szymczak, PhD, Associate Professor in the Division of Epidemiology and Co-Director of the Utah Quality Advancement Laboratory, $12 million in research funding for a study that will compare two ways to use antibiotics in young children with pneumonia mild enough that they do not need to be hospitalized. Dr. Szymczak is jointly leading the trial with Todd Florin, MD, MSCE, Associate Division Head for Academic Affairs and Research in the Division of Emergency Medicine at Ann & Robert H. Lurie Children’s Hospital of Chicago, and Associate Professor of Pediatrics at Northwestern University Feinberg School of Medicine. The Utah Data Coordinating Center (DCC) is coordinating this multicenter trial. University of Utah Co-Investigators include Charlie Casper, PhD, Professor in the Division of Critical Care, Department of Pediatrics and Sarah M. Becker, DO, Assistant Professor in the Division of Pediatric Emergency Medicine at Intermountain Primary Children’s Hospital.
The broad pragmatic trial will compare two ways of treating children with mild pneumonia. The first approach is to prescribe and give antibiotics immediately, which is the current standard of care. The second way is to prescribe an antibiotic but not give it unless the child’s symptoms worsen or do not improve within three days, an approach that is known as a Safety-Net Antibiotic Prescription (SNAP). The study aims to determine whether SNAP, compared to immediate prescribing, results in decreased antibiotic use and similar clinical improvement in children with mild pneumonia.
“Most pneumonias in young children are caused by a virus, which the body fights off without antibiotics. Despite this, most children with pneumonia are currently treated with antibiotics,” said Dr. Florin. “It is important to avoid exposing children to unnecessary antibiotics for many reasons, including their side effects, such as rashes that can mimic allergies or an upset stomach. We also want to avoid the development of antibiotic-resistant bacteria, a global health threat. A SNAP treatment strategy is currently recommended for ear infections in children and has safely decreased antibiotic use for this condition. This strategy has not been evaluated in pneumonia. We hope our study shows a similar impact and identifies factors that influence implementation of a SNAP strategy.”
The research team is working with 12 pediatric primary care offices and three urgent care centers that are part of the Pediatric Research Consortium at The Children’s Hospital of Philadelphia, and four pediatric emergency departments across the country, including Utah’s Intermountain Primary Children’s Hospital and Ann & Robert H. Lurie Children’s, to enroll 1,823 children between 1 and 6 years of age who have been diagnosed with mild pneumonia. The team will assign children randomly to a group that receives immediate antibiotic prescribing or to a group that uses the SNAP approach.
The research team will follow up with the parent/guardian three times over the 14 days after the child's appointment to collect information about symptom improvement, antibiotic use, return to healthcare, child quality of life, parent satisfaction, and antibiotic side effects. The research team will also study how SNAP is implemented by talking to parents/guardians and pediatricians about factors that might make it easier or harder to use this approach.
“The decision to compare immediate antibiotic prescribing and the SNAP approach was informed by our research on how parents and pediatricians feel about navigating the care of children with pneumonia in real-world settings,” said Dr. Szymczak. “It is important for researchers to generate evidence that patients and clinicians need to guide difficult healthcare decisions, such as when to use an antibiotic. Nobody wants to give unnecessary medicine, but it is scary to care for a child with pneumonia, and it’s often unclear whether an antibiotic will help. SNAP empowers parents to give their child a chance to fight off the infection on their own while also having fast access to antibiotics if it becomes clear they are needed.”
The study was selected through PCORI’s highly competitive review process in which patients, caregivers, and other stakeholders join scientists to evaluate proposals. The formal award contract has been issued, and the trial began on December 1.
PCORI is an independent, nonprofit organization authorized by Congress with a mission to fund patient-centered comparative clinical effectiveness research that provides patients, their caregivers, and clinicians with the evidence-based information they need to make better-informed health and healthcare decisions. To read more about this trial, please visit the project abstract.