Evaluation of a New Clinical Endpoint for Moderate to Severe Influenza Disease in Children: A Prospective Cohort Study

Author:

Rao Suchitra1,Yanni Emad2,Moss Angela3,Lamb Molly M4,Schuind Anne2,Bekkat-Berkani Rafik5,Innis Bruce L2,Cotter Jillian6,Mistry Rakesh D7,Asturias Edwin J8

Affiliation:

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

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.

Funder

GlaxoSmithKline Biologicals SA

National Institutes of Health

National Center for Advancing Translational Sciences

Colorado Clinical and Translational Sciences Institute

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,General Medicine,Pediatrics, Perinatology, and Child Health

Reference32 articles.

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