title: Clinical Predictors of Critical Lower Respiratory Tract Illness Due to Respiratory Syncytial Virus in Infants and Children: Data to Inform Case Definitions for Efficacy Trials.
abstract: We analyzed data from 524 Argentinean infants hospitalized with lower respiratory tract illness (LRTI) due to respiratory syncytial virus (RSV) to inform selection of clinical end points for RSV vaccine efficacy trials. Cases of LRTI due to RSV that required a mask, continuous or bilevel positive airway pressure, or mechanical ventilation were classified as critical. Oxygen saturation of ≤90%, tachypnea, and tachycardia were each associated with an increased odds of critical LRTI due to RSV (adjusted odds ratios [ORs], 2.30 [95% confidence interval {CI}, 1.26-4.24; P = .007], 2.22 [95% CI, 1.19-4.16; P = .012], and 2.35 [95% CI, 1.22-4.50; P = .010], respectively). The odds of critical LRTI due to RSV increased substantially (OR, 8.57; 95% CI, 2.19-73.5; P = .001) among individuals with ≥2 indicators. Lower chest wall indrawing was not associated with critical disease.
authors.affiliation: Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
authors.forename: Jessica E
authors.initials: JE
authors.lastname: Atwell
authors.affiliation: Fundación INFANT, Buenos Aires, Argentina.|Temple Street Children's University Hospital, Dublin, Ireland.
authors.forename: Sarah
authors.initials: S
authors.lastname: Geoghegan
authors.affiliation: Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
authors.forename: Ruth A
authors.initials: RA
authors.lastname: Karron
authors.affiliation: Vanderbilt University, Nashville, Tennessee.|Fundación INFANT, Buenos Aires, Argentina.
authors.forename: Fernando P
authors.initials: FP
authors.lastname: Polack
mesh_terms: D001118:Argentina; D002675:Child, Preschool; D003430:Cross-Sectional Studies; D003661:Decision Support Techniques; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D011024:Pneumonia, Viral / Q000175:diagnosis* / Q000473:pathology*; D011446:Prospective Studies; D018357:Respiratory Syncytial Virus Infections / Q000175:diagnosis* / Q000473:pathology*; D012136:Respiratory Syncytial Viruses / Q000302:isolation & purification*
keywords: case definitions; clinical development; respiratory syncytial virus; vaccine