Encephalitic Infection, Fever, Influenza, Lower Resp Tract Infection, Myositis Viral, Otitis Media
Conditions
Keywords
hospitalization, intensive care unit, school absenteeism, work absenteeism
Brief 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.
Detailed 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.
Interventions
PROCEDURERespiratory nasal swab
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.
Sponsors
GlaxoSmithKline
University of Colorado, Denver
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
6 Months to 8 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization | 0-14 days | Hospitalization within 14 days of influenza infection diagnosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU Admission | 0-14 days | Admission to the intensive care unit after influenza diagnosis |
| Antiviral Use | 0-14 days | Antiviral use in children presenting to the ED or urgent care with influenza |
| Antibiotic Use | 0-14 days | Antibiotic use in children presenting to the ED or urgent care with influenza |
| School Absenteeism | 0-14 days | Absenteeism from school or daycare in patients presenting to the ED or urgent care with influenza |
| Work Absenteeism | 0-14 days | Absenteeism from work in caregivers of children presenting to the ED or urgent care with influenza |
| Recurrent Visits | 0-14 days | Recurrent visits to the ED or healthcare provider in children presenting to the ED or urgent care with influenza |
Other
| Measure | Time frame | Description |
|---|---|---|
| Injectable Influenza Vaccine (IIV) Hospitalization | 0-14 days | Hospitalization among children who received IIV presenting to the ED or urgent care with influenza. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred from January 30, 2017 until 5 May of 2018 including 2 influenza seasons at the Children's Hospital Colorado main Emergency Department and a peripheral Urgent Care Center
Participants by arm
| Arm | Count |
|---|---|
| Moderate-to-severe Influenza 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)
Respiratory nasal swab: 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. | 313 |
| Mild Influenza Children 6 weeks to 8 years of age with influenza-like illness (ILI) without the criteria for moderate-to-severe disease (above)
Respiratory nasal swab: 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. | 98 |
| Total | 411 |
Baseline characteristics
| Characteristic | Mild Influenza | Total | Moderate-to-severe Influenza |
|---|---|---|---|
| Age, Continuous | 4.8 years STANDARD_DEVIATION 2.4 | 4 years STANDARD_DEVIATION 1.8 | 3.8 years STANDARD_DEVIATION 1.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 38 Participants | 24 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 69 Participants | 265 Participants | 196 Participants |
| Race (NIH/OMB) White | 15 Participants | 108 Participants | 93 Participants |
| Sex: Female, Male Female | 53 Participants | 205 Participants | 152 Participants |
| Sex: Female, Male Male | 45 Participants | 206 Participants | 161 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 313 | 0 / 98 |
| other Total, other adverse events | 0 / 313 | 0 / 98 |
| serious Total, serious adverse events | 0 / 313 | 0 / 98 |
Outcome results
Primary
Hospitalization
Hospitalization within 14 days of influenza infection diagnosis
Time frame: 0-14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Moderate-to-severe Influenza | Hospitalization | 26 Participants |
| Mild Influenza | Hospitalization | 2 Participants |
Secondary
Antibiotic Use
Antibiotic use in children presenting to the ED or urgent care with influenza
Time frame: 0-14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Moderate-to-severe Influenza | Antibiotic Use | 96 Participants |
| Mild Influenza | Antibiotic Use | 17 Participants |
Secondary
Antiviral Use
Antiviral use in children presenting to the ED or urgent care with influenza
Time frame: 0-14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Moderate-to-severe Influenza | Antiviral Use | 63 Participants |
| Mild Influenza | Antiviral Use | 17 Participants |
Secondary
ICU Admission
Admission to the intensive care unit after influenza diagnosis
Time frame: 0-14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Moderate-to-severe Influenza | ICU Admission | 3 Participants |
| Mild Influenza | ICU Admission | 0 Participants |
Secondary
Recurrent Visits
Recurrent visits to the ED or healthcare provider in children presenting to the ED or urgent care with influenza
Time frame: 0-14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Moderate-to-severe Influenza | Recurrent Visits | 21 Participants |
| Mild Influenza | Recurrent Visits | 4 Participants |
Secondary
School Absenteeism
Absenteeism from school or daycare in patients presenting to the ED or urgent care with influenza
Time frame: 0-14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Moderate-to-severe Influenza | School Absenteeism | 87 Participants |
| Mild Influenza | School Absenteeism | 85 Participants |
Secondary
Work Absenteeism
Absenteeism from work in caregivers of children presenting to the ED or urgent care with influenza
Time frame: 0-14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Moderate-to-severe Influenza | Work Absenteeism | 71 Participants |
| Mild Influenza | Work Absenteeism | 63 Participants |
Other Pre-specified
Injectable Influenza Vaccine (IIV) Hospitalization
Hospitalization among children who received IIV presenting to the ED or urgent care with influenza.
Time frame: 0-14 days
Population: Outcome measure data is not required to be reported for this other pre-specified (not primary or secondary) outcome measure.