Leveraging real-world Data from administrative claims and medical records to inform safety and effectiveness of piperacillin-tazobactam in the Management of Pediatric Hospital Acquired Pneumonia

Jesse A. Blumenstock, Division of Infectious Diseases, Department of Pediatrics, Children's Hospital of Philadelphia (CHOP), Philadelphia, Pennsylvania, USA.
Jennifer A. Faerber, Department of Biomedical and Health Informatics, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.
Muida Menon, Division of Infectious Diseases, Department of Pediatrics, Children's Hospital of Philadelphia (CHOP), Philadelphia, Pennsylvania, USA.
Rasheeda Lawler, Division of Infectious Diseases, Department of Pediatrics, Children's Hospital of Philadelphia (CHOP), Philadelphia, Pennsylvania, USA.
Kevin J. Downes, Division of Infectious Diseases, Department of Pediatrics, Children's Hospital of Philadelphia (CHOP), Philadelphia, Pennsylvania, USA.
Ellen Kratz, Division of Infectious Diseases, Department of Pediatrics, Children's Hospital of Philadelphia (CHOP), Philadelphia, Pennsylvania, USA.
Kelley Erickson, Cancer and Blood Disorders Center, Oncology, Seattle Children's, Seattle, Washington, USA.
Brittany Haltzman-Cassenti, Patient Services, MDGroup, Durham, North Carolina, USA.
Inci Yildirim, Yale Institute for Global Health, New Haven, Connecticut, USA.
Laila Hussaini, Pediatric Infectious Diseases, Emory School of Medicine, Atlanta, Georgia, USA.
Mohnd Elmontser, Anatomic & Clinical Pathology, St. Louis University, St. Louis, Missouri, USA.
Bethany K. Sederdahl, Department of Pediatrics, Emory University, Atlanta, Georgia, USA.
Andrea Hahn, Division of Infectious Diseases, Children's National Hospital, Washington, DC, USA.
Joanna Thomson, Division of Hospital Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Jason Newland, Department of Pediatrics, Washington University School of Medicine, St. Louis, St. Louis, Missouri, USA.
Cindy Terrill, Department of Pediatrics, Washington University School of Medicine, St. Louis, St. Louis, Missouri, USA.
John Bradley, Department of Pediatrics, Division of Infectious Diseases, University of California at San Diego, La Jolla, California, USA.
Phillip Zachariah, Department of Pediatrics, Columbia University Irving Medical Center, New York, New York, USA.
Muhammad Younus, Safety Surveillance Research, Pfizer, Collegeville, Pennsylvania, USA.
Jingping Mo, Safety Surveillance Research, Pfizer, Collegeville, Pennsylvania, USA.
Michele Wible, Global Product Development, Pfizer, Collegeville, Pennsylvania, USA.
Margaret Tawadrous, Global Product Development, Pfizer, Collegeville, Pennsylvania, USA.
Brian T. Fisher, Division of Infectious Diseases, Department of Pediatrics, Children's Hospital of Philadelphia (CHOP), Philadelphia, Pennsylvania, USA.

Document Type

Journal Article

Publication Date

8-6-2024

Journal

American journal of epidemiology

DOI

10.1093/aje/kwae251

Abstract

Pediatric-specific safety data are required during development of pharmaceutical agents. Retrospective studies can leverage real-world data to assess safety and effectiveness in children where prospective, controlled studies are not feasible. A retrospective cohort study combined data from Pediatric Health Information Systems (PHIS) and medical records to evaluate the safety and effectiveness of piperacillin/tazobactam (P/T) in pediatric patients with hospital-acquired pneumonia (HAP). After identifying 407 patients diagnosed with HAP receiving P/T (n=140) or Comparator (n=267) HAP-appropriate antibiotics between 2003-2016 across seven pediatric institutions, we evaluated comparative risk of a serious adverse event (SAE). Clinical improvement 14 days after therapy initiation was studied as a secondary outcome. Incidence rate ratios (IRRs) were calculated to compare between exposure groups using inverse probability-weighted Poisson regression models. The unadjusted and adjusted IRRs with 95% CIs for SAEs were 1.26(0.66-2.39) and 1.24(0.65-2.35). The unadjusted and adjusted ORs with 95% CIs for clinical improvement were 1.14(0.56-2.34) and 1.50(0.67-3.38). Point estimates from this retrospective analysis suggest similar safety and clinical effectiveness of P/T and comparator antibiotics for treating HAP. However, due to wide CIs, actual between-group differences cannot be excluded. Existing real-world data can be utilized to inform pediatric-specific safety and effectiveness of medications used in off-label settings.

Department

Pediatrics

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