Jessica E Ericson1, John McGuire2, Marian G Michaels3, Adam Schwarz4, Robert Frenck5, Jaime G Deville6, Swati Agarwal7, Adam M Bressler8, Jamie Gao9, Tracy Spears9, Daniel K Benjamin1, P Brian Smith1, John S Bradley1. 1. From the Penn State College of Medicine, Hershey, Pennsylvania. 2. Seattle Children's Hospital, Seattle, Washington. 3. UPMC Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania. 4. Children's Hospital of Orange County, Orange, California. 5. Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, Ohio. 6. UCLA Mattel Children's Hospital, Los Angeles, California. 7. Inova Children's Hospital, Falls Church, Virginia. 8. Atlanta Institute for Medical Research, Atlanta, Georgia. 9. Duke Clinical Research Institute, Durham, North Carolina.
Abstract
BACKGROUND: Clinical trials for antibiotics designed to treat hospital-acquired and ventilator-associated bacterial pneumonias (HABP/VABP) are hampered by making these diagnoses in a way that is acceptable to the United States Food and Drug Administration and consistent with standards of care. We examined laboratory and clinical features that might improve pediatric HABP/VABP trial efficiency by identifying risk factors predisposing children to HABP/VABP and describing the epidemiology of pediatric HABP/VABP. METHODS: We prospectively reviewed the electronic medical records of patients <18 years of age admitted to intensive and intermediate care units (ICUs) if they received qualifying respiratory support or were started on antibiotics for a lower respiratory tract infection or undifferentiated sepsis. Subjects were followed until HABP/VABP was diagnosed or they were discharged from the ICU. Clinical, laboratory and imaging data were abstracted using structured chart review. We calculated HABP/VABP incidence and used a stepwise backward selection multivariable model to identify risk factors associated with development of HABP/VABP. RESULTS: A total of 862 neonates, infants and children were evaluated for development of HABP/VABP; 10% (82/800) of those receiving respiratory support and 12% (103/862) overall developed HABP/VABP. Increasing age, shorter height/length, longer ICU length of stay, aspiration risk, blood product transfusion in the prior 7 days and frequent suctioning were associated with increased odds of HABP/VABP. The use of noninvasive ventilation and gastric acid suppression were both associated with decreased odds of HABP/VABP. CONCLUSIONS: Food and Drug Administration-defined HABP/VABP occurred in 10%-12% of pediatric patients admitted to ICUs. Risk factors vary by age group.
BACKGROUND: Clinical trials for antibiotics designed to treat hospital-acquired and ventilator-associated bacterial pneumonias (HABP/VABP) are hampered by making these diagnoses in a way that is acceptable to the United States Food and Drug Administration and consistent with standards of care. We examined laboratory and clinical features that might improve pediatric HABP/VABP trial efficiency by identifying risk factors predisposing children to HABP/VABP and describing the epidemiology of pediatric HABP/VABP. METHODS: We prospectively reviewed the electronic medical records of patients <18 years of age admitted to intensive and intermediate care units (ICUs) if they received qualifying respiratory support or were started on antibiotics for a lower respiratory tract infection or undifferentiated sepsis. Subjects were followed until HABP/VABP was diagnosed or they were discharged from the ICU. Clinical, laboratory and imaging data were abstracted using structured chart review. We calculated HABP/VABP incidence and used a stepwise backward selection multivariable model to identify risk factors associated with development of HABP/VABP. RESULTS: A total of 862 neonates, infants and children were evaluated for development of HABP/VABP; 10% (82/800) of those receiving respiratory support and 12% (103/862) overall developed HABP/VABP. Increasing age, shorter height/length, longer ICU length of stay, aspiration risk, blood product transfusion in the prior 7 days and frequent suctioning were associated with increased odds of HABP/VABP. The use of noninvasive ventilation and gastric acid suppression were both associated with decreased odds of HABP/VABP. CONCLUSIONS: Food and Drug Administration-defined HABP/VABP occurred in 10%-12% of pediatric patients admitted to ICUs. Risk factors vary by age group.
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