N/A
Completed N=411
Evaluation of Moderate to Severe Influenza Outcomes in Children
Influenza · Chronic Otitis Media · Lower Resp Tract Infection · Encephalitic Infection
Source: ClinicalTrials.gov NCT02979626 ↗
Enrolled (actual)
411
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcomePrimary: Hospitalization — 26; 2 Participants
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.
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 | — |
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
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. Informational only — not medical advice.