N/A N=411

Evaluation of Moderate to Severe Influenza Outcomes in Children

Influenza · Otitis Media · Lower Resp Tract Infection · Encephalitic Infection · Myositis Viral

Bottom Line

View on ClinicalTrials.gov: NCT02979626 ↗

Enrolled (actual)

411

Serious AEs

0.0%

Results posted

Feb 2021

Primary outcome: Primary: Hospitalization — 26; 2 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Respiratory nasal swab (Procedure)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: University of Colorado, Denver
Primary completion: May 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Hospitalization	26; 2	—
SECONDARY ICU Admission	3; 0	—
SECONDARY Antiviral Use	63; 17	—
SECONDARY Antibiotic Use	96; 17	—
SECONDARY Recurrent Visits	21; 4	—
SECONDARY School Absenteeism	87; 85	—
SECONDARY Work Absenteeism	71; 63	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Age 6 months to 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02979626). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.