Suchitra Rao1, Emad Yanni2, Angela Moss3, Molly M Lamb4, Anne Schuind2, Rafik Bekkat-Berkani5, Bruce L Innis2, Jillian Cotter6, Rakesh D Mistry7, Edwin J Asturias8. 1. Department of Pediatrics (Infectious Diseases, Hospital Medicine and Epidemiology), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado, USA. 2. GSK, Rockville, Maryland, USA. 3. Department of Pediatrics, University of Colorado School of Medicine and Children's Hospital Colorado and Adult and Child Center for Health Outcomes Research and Delivery Science, Aurora, Colorado, USA. 4. Department of Epidemiology and Center for Global Health, Colorado School of Public Health, Aurora, Colorado, USA. 5. GSK, Philadelphia, Pennsylvania, USA. 6. Department of Pediatrics (Hospital Medicine), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado, USA. 7. Department of Pediatrics (Emergency Medicine), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora, Colorado, USA. 8. Department of Pediatrics, University of Colorado School of Medicine, Department of Epidemiology and Center for Global Health, Colorado School of Public Health, Aurora, Colorado, USA.
Abstract
BACKGROUND: A moderate to severe (M/S) influenza clinical endpoint has been proposed in children, defined as fever >39°C, otitis media, lower respiratory tract infection, or serious extrapulmonary manifestations. The objective of the study was to evaluate the M/S measure against clinically relevant outcomes including hospitalization, emergency room visits, antimicrobial use, and child/parental absenteeism. METHODS: We conducted a prospective observational study of children aged 6 months-8 years at the Children's Hospital Colorado emergency department (ED) and urgent care site during 2016-2017 and 2017-2018. Children with influenza-like illness (ILI) underwent influenza testing by polymerase chain reaction (PCR); children who tested positive and a subset of matched test-negative controls underwent follow-up at 2 weeks. The primary outcome was the proportion of children who were hospitalized. Secondary outcomes included recurrent ED visits, antimicrobial use, hospital charges, and child/parental absenteeism within 14 days. RESULTS: Among 1478 children enrolled with ILI, 411 (28%) tested positive for influenza by PCR. Of children with influenza illness, 313 (76%) met the M/S definition. Children with M/S influenza were younger (3.8 years vs 4.8 years), infected with influenza A (59% vs 44%), and more frequently hospitalized (unadjusted risk difference [RD], 6.3%; 95% confidence interval [CI], 2.1-10.4; P = .03) and treated with antibiotics (unadjusted RD, 13.3%; 95% CI, 4.3-22.4; P < .01) compared to those with mild disease. CONCLUSIONS: Children with M/S influenza have a higher risk of hospitalization and antibiotic use compared with mild disease. This proposed definition may be a useful clinical endpoint to study the public health and clinical impact of influenza interventions in children. CLINICAL TRIALS REGISTRATION: NCT02979626.
BACKGROUND: A moderate to severe (M/S) influenza clinical endpoint has been proposed in children, defined as fever >39°C, otitis media, lower respiratory tract infection, or serious extrapulmonary manifestations. The objective of the study was to evaluate the M/S measure against clinically relevant outcomes including hospitalization, emergency room visits, antimicrobial use, and child/parental absenteeism. METHODS: We conducted a prospective observational study of children aged 6 months-8 years at the Children's Hospital Colorado emergency department (ED) and urgent care site during 2016-2017 and 2017-2018. Children with influenza-like illness (ILI) underwent influenza testing by polymerase chain reaction (PCR); children who tested positive and a subset of matched test-negative controls underwent follow-up at 2 weeks. The primary outcome was the proportion of children who were hospitalized. Secondary outcomes included recurrent ED visits, antimicrobial use, hospital charges, and child/parental absenteeism within 14 days. RESULTS: Among 1478 children enrolled with ILI, 411 (28%) tested positive for influenza by PCR. Of children with influenza illness, 313 (76%) met the M/S definition. Children with M/S influenza were younger (3.8 years vs 4.8 years), infected with influenza A (59% vs 44%), and more frequently hospitalized (unadjusted risk difference [RD], 6.3%; 95% confidence interval [CI], 2.1-10.4; P = .03) and treated with antibiotics (unadjusted RD, 13.3%; 95% CI, 4.3-22.4; P < .01) compared to those with mild disease. CONCLUSIONS:Children with M/S influenza have a higher risk of hospitalization and antibiotic use compared with mild disease. This proposed definition may be a useful clinical endpoint to study the public health and clinical impact of influenza interventions in children. CLINICAL TRIALS REGISTRATION: NCT02979626.
Authors: Matthew R Kasper; Thomas F Wierzba; Ly Sovann; Patrick J Blair; Shannon D Putnam Journal: BMC Infect Dis Date: 2010-11-07 Impact factor: 3.090
Authors: Carine Claeys; Khalequ Zaman; Ghassan Dbaibo; Ping Li; Allen Izu; Pope Kosalaraksa; Luis Rivera; Beatriz Acosta; Maria Luisa Arroba Basanta; Asma Aziz; Miguel Angel Cabanero; Vijayalakshmi Chandrashekaran; Bartholomew Corsaro; Luis Cousin; Adolfo Diaz; Javier Diez-Domingo; Ener Cagri Dinleyici; Saul N Faust; Damien Friel; Jose Garcia-Sicilia; Grace D Gomez-Go; Maria Liza Antoinette Gonzales; Stephen M Hughes; Teresa Jackowska; Shashi Kant; Marilla Lucero; Ludovic Malvaux; Josep Mares Bermudez; Federico Martinon-Torres; Mariano Miranda; May Montellano; Maria Amor Peix Sambola; Roman Prymula; Thanyawee Puthanakit; Renata Ruzkova; Iwona Sadowska-Krawczenko; Ignacio Salamanca de la Cueva; Etienne Sokal; Jyoti Soni; Henryk Szymanski; Angels Ulied; Anne Schuind; Varsha K Jain; Bruce L Innis Journal: Lancet Child Adolesc Health Date: 2018-03-05
Authors: Lisa A Grohskopf; Sonja J Olsen; Leslie Z Sokolow; Joseph S Bresee; Nancy J Cox; Karen R Broder; Ruth A Karron; Emmanuel B Walter Journal: MMWR Morb Mortal Wkly Rep Date: 2014-08-15 Impact factor: 17.586