Research In Practice Blog

In the United States, pneumonia is a significant health concern for children. Although it is less common than other respiratory infections, it stands as a leading cause of childhood hospitalizations. According to data from the National Syndromic Surveillance Program (NSSP), approximately 1.7% of emergency department visits among children aged 0-1 years, 2.4% among children aged 2-4 years, and 1.5% among children aged 5-17 years, are attributed to pneumonia.

Researchers from Ann & Robert H. Lurie Children’s Hospital of Chicago, in collaboration with University of Utah Health and Children's Hospital of Philadelphia (CHOP), have received $12 million in funding to investigate the most effective methods for treating mild pneumonia in young children. CHOP will play a crucial role in this study by contributing all primary and urgent care data.

Data will be collected from up to 12 primary care centers and four urgent care sites. Funding for the study was provided by the Patient-Centered Outcomes Research Institute (PCORI). PCORI, an independent nonprofit organization, is the leading funder of patient-centered comparative clinical effectiveness research in the United States.

Building on the efforts at the CHOP sites, researchers and statisticians will conduct a thorough analysis of data gathered from four pediatric emergency departments (EDs) nationwide. The recruitment process and follow-up activities in these EDs will be spearheaded by Todd Florin, MD, MSCE, who serves as the principal investigator for the overall study. As a former CHOP resident and the current Associate Division Head for Academic Affairs and Research in the Division of Emergency Medicine at Lurie Children’s Hospital of Chicago, Dr. Florin brings valuable expertise to this important work.

The participating pediatric primary care offices and urgent care centers from CHOP are part of the Pediatric Research Consortium (PeRC) at CHOP. PeRC optimizes the ever-improving functionality of the electronic health record, develops mentoring relationships with faculty and trainees, advances practice-based research methods, and supports research within the context of clinical care. PeRC’s primary care practice-based network is a nationally and internationally recognized entity for the advancement of primary care research and enhances CHOP's position as a national and international leader in pediatric research.  The study aims to enroll 1,823 children aged 1 to 6 years who have been diagnosed with mild pneumonia.

Methodology

The study will compare two approaches for treating mild pneumonia in young children:

• The first approach involves immediately prescribing and administering antibiotics, which is the current standard of care.
• The second approach is to provide a prescription for antibiotics but only administer them if the child's symptoms worsen or do not improve within three days. This method is known as a Safety-Net Antibiotic Prescription (SNAP).

Children who participate in the study will be randomly assigned to one of two groups: one group will receive immediate antibiotic prescriptions, while the other group will follow the SNAP approach. The primary aim of the study is to thoroughly assess whether the SNAP approach, in comparison to immediate antibiotic prescribing, can lead to a notable reduction in overall antibiotic usage, while ensuring that clinical outcomes for children remain comparable. This research could play a crucial role in promoting responsible antibiotic stewardship, which is vital in combating antibiotic resistance, while also striving for optimal health outcomes for young patients battling mild pneumonia.

The research team will follow up with the patients’ parents and guardians 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 team will also study how the SNAP approach is implemented by speaking with parents, guardians, and pediatricians about factors that may make this approach easier or more challenging to use.

Partners and Collaborators

Clinical Futures’ investigators Jeffrey Gerber, MD, PhD, and Kathleen Chiotos, MD, MSCE, will lead the charge in recruiting patients at CHOP in primary care and emergent care settings with the help of PeRC partners, fondly called “clinical champions,” at these locations. CHOP is uniquely positioned to facilitate this type of study because of its patient population and dynamic outpatient care settings. 

Dr. Gerber stated, "In the fields of infectious disease and antibiotic stewardship, we are constantly seeking ways to not only evaluate the effectiveness of antibiotics but also to combat their overuse and over-prescription, which can lead to antibiotic resistance. Additionally, we aim to avoid the unnecessary side effects from medications that may not be needed."

Dr. Chiotos and co-principal investigator to Dr. Florin, Julia Szymczak, PhD, an Associate Professor in the Division of Epidemiology at the University of Utah School of Medicine and a former postdoctoral fellow at CHOP and currently an affiliate faculty member at Clinical Futures, will be tasked with examining the implementation of SNAP to evaluate its effectiveness as a potential best practice for treating mild pneumonia cases in young children. They aim to gather insights on how parents and physicians perceive different approaches to diagnosing pneumonia in real-world clinical settings. 

This study presents a unique and important collaboration between experienced investigators, key stakeholders and clinical champions in PeRC, and organizations with expertise in facilitating multicenter research.

Dr. Chiotos expressed her enthusiasm for the study, saying, “I am excited to start this study and thankful to PCORI for the funding that will allow us to begin this collaborative effort with Drs. Florin and Szymczak. The study has the potential to help healthcare providers optimize antibiotic use for patients with pneumonia in real-world settings.” 

Research in Practice Implications

This project stands as a powerful testament to the collaboration between hospital systems and like-minded scientists who are harnessing dynamic environments and diverse patient populations to drive meaningful scientific progress.

For more information, read the project summary on PCORI’s website and this Cornerstone Blog post from the CHOP Research Institute.

The study was selected through PCORI’s highly competitive review process in which patients, caregivers and other stakeholders join scientists to evaluate proposals. The award has been approved pending completion of PCORI’s business and programmatic review and issuance of a formal award contract.
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 health care decisions.