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Completed

NCT Number: NCT02979626

Evaluation of Moderate to Severe Influenza Outcomes in Children

The purpose of this study was to determine whether moderate-severe endpoints (including high fever, lower respiratory tract disease, acute otitis media, or serious extra-pulmonary complications) were predictive of hospitalization, intensive care admission, antibiotic use and other complications in children under 8 years of age.

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Key information

Conditions

Influenza Body Temperature Changes Brain Diseases Central Nervous System Diseases Ear Diseases Encephalitic Infection Encephalitis Fever Infections Influenza, Human Lower Resp Tract Infection Myositis Viral Nervous System Diseases Neuroinflammatory Diseases Orthomyxoviridae Infections Otitis Otitis Media Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases

Age range

6 month–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado, Aurora, Colorado, United States

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About this study

This prospective observational study aimed to determine the risk difference of hospitalization due to moderate to severe influenza compared with mild influenza among children aged 6 months to 8 years who were evaluated at Children's Hospital Colorado emergency department and urgent care during the 2016-2017 influenza season. In addition, the study intended to evaluate the risk difference for other health outcomes such as ICU admission, antibiotic and antiviral use, caregiver and child absenteeism and recurrent (>1) healthcare visits, and to compare the healthcare costs associated with management of moderate to severe versus mild influenza in children. Children who presented to Children's Hospital Colorado Emergency Department (ED) and urgent care affiliated sites (North Campus urgent care) with an influenza-like illness from December 2016 to April 2017 and during the 2016-2017 influenza season, were eligible for the study. Once enrolled in the study, the investigators collected respiratory samples (nasal swab specimens) for influenza testing by PCR, sociodemographic and clinical data including variables of interest outlined above, and followed the clinical outcome of these children for 14 days after their initial presentation. Some of the variables of interest the investigators collected are shown below.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 6 months to < 8 years
  • Presentation to one of the study sites with signs and symptoms of influenza-like illness (temperature of >37.8⁰C and at least one of the following: cough, sore throat, runny nose or nasal congestion)
  • Parents or guardians agreeing and consenting to medical information release, respiratory specimen collection and testing, email/phone call follow up and collection of leftover blood samples obtained during routine clinical care
  • Patients seen during the 2016-2017 influenza season

Exclusion criteria

  • Respiratory symptom duration > 14 days
  • Nurse only visit
  • Enrollment in the study within prior 14 days

Treatment and study plan

Respiratory nasal swab

Procedure

Nasal swabs will be obtained for testing by the study nurses. If a respiratory sample has already been collected as part of routine clinical care, this will replace the study collection, and no additional testing will be required.

Other names: Nasal swab

Primary outcomes

  1. Hospitalization

    Time frame: 0-14 days

    Hospitalization within 14 days of influenza infection diagnosis

Secondary outcomes

  1. ICU Admission

    Time frame: 0-14 days

    Admission to the intensive care unit after influenza diagnosis

  2. Antiviral Use

    Time frame: 0-14 days

    Antiviral use in children presenting to the ED or urgent care with influenza

  3. Antibiotic Use

    Time frame: 0-14 days

    Antibiotic use in children presenting to the ED or urgent care with influenza

  4. Recurrent Visits

    Time frame: 0-14 days

    Recurrent visits to the ED or healthcare provider in children presenting to the ED or urgent care with influenza

  5. School Absenteeism

    Time frame: 0-14 days

    Absenteeism from school or daycare in patients presenting to the ED or urgent care with influenza

  6. Work Absenteeism

    Time frame: 0-14 days

    Absenteeism from work in caregivers of children presenting to the ED or urgent care with influenza

Other outcomes

  1. Injectable Influenza Vaccine (IIV) Hospitalization

    Time frame: 0-14 days

    Hospitalization among children who received IIV presenting to the ED or urgent care with influenza.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Evaluation of Moderate to Severe Influenza Disease in Children 6 Months to 8 Years in Colorado

Acronym: M2SFlu

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 1, 2016
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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