Evaluation of Moderate to Severe Influenza Outcomes in Children (M2SFlu)

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Fever; Influenza; Myositis Viral; Lower Resp Tract Infection; Otitis Media; Encephalitic Infection

Treatments: Procedure: Respiratory nasal swab

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02979626

16-1785

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,478 patients

Sex: All

Ages: 6 months to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

1,478 participants in 2 patient groups

Moderate-to-severe Influenza

Description:

Children 6 weeks to 8 years of age with influenza-like illness and one of the following: 1. Fever \>39 2. Lower respiratory tract infection 3. Acute otitis media 4. Serious extra-pulmonary manifestations (myositis, encephalitis)

Treatment:

Procedure: Respiratory nasal swab

Mild Influenza

Description:

Children 6 weeks to 8 years of age with influenza-like illness (ILI) without the criteria for moderate-to-severe disease (above)

Treatment:

Procedure: Respiratory nasal swab