Trial Outcomes & Findings for Evaluation of Moderate to Severe Influenza Outcomes in Children (NCT NCT02979626)

NCT ID: NCT02979626

Last Updated: 2021-02-04

Results Overview

Hospitalization within 14 days of influenza infection diagnosis

• Recruitment status: COMPLETED
• Target enrollment: 1478 participants
• Primary outcome timeframe: 0-14 days
• Results posted on: 2021-02-04

Participant Flow

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

Participant milestones

Measure	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.	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.
Overall Study STARTED	313	98
Overall Study COMPLETED	313	98
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Subjects analyzed are ONLY influenza positive confirmed

Baseline characteristics by cohort

Measure	Moderate-to-severe Influenza n=313 Participants 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.	Mild Influenza n=98 Participants 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.	Total n=411 Participants Total of all reporting groups
Age, Continuous	3.8 years STANDARD_DEVIATION 1.8 • n=5 Participants • Subjects analyzed are ONLY influenza positive confirmed	4.8 years STANDARD_DEVIATION 2.4 • n=7 Participants • Subjects analyzed are ONLY influenza positive confirmed	4 years STANDARD_DEVIATION 1.8 • n=5 Participants • Subjects analyzed are ONLY influenza positive confirmed
Sex: Female, Male Female	152 Participants n=5 Participants	53 Participants n=7 Participants	205 Participants n=5 Participants
Sex: Female, Male Male	161 Participants n=5 Participants	45 Participants n=7 Participants	206 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	24 Participants n=5 Participants	14 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) White	93 Participants n=5 Participants	15 Participants n=7 Participants	108 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	196 Participants n=5 Participants	69 Participants n=7 Participants	265 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0-14 days

Hospitalization within 14 days of influenza infection diagnosis

Outcome measures

Measure	Moderate-to-severe Influenza n=313 Participants 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.	Mild Influenza n=98 Participants 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.
Hospitalization	26 Participants	2 Participants

SECONDARY outcome

Timeframe: 0-14 days

Admission to the intensive care unit after influenza diagnosis

Outcome measures

Measure	Moderate-to-severe Influenza n=313 Participants 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.	Mild Influenza n=98 Participants 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.
ICU Admission	3 Participants	0 Participants

SECONDARY outcome

Timeframe: 0-14 days

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

Outcome measures

Measure	Moderate-to-severe Influenza n=313 Participants 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.	Mild Influenza n=98 Participants 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.
Antiviral Use	63 Participants	17 Participants

SECONDARY outcome

Timeframe: 0-14 days

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

Outcome measures

Measure	Moderate-to-severe Influenza n=313 Participants 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.	Mild Influenza n=98 Participants 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.
Antibiotic Use	96 Participants	17 Participants

SECONDARY outcome

Timeframe: 0-14 days

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

Outcome measures

Measure	Moderate-to-severe Influenza n=313 Participants 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.	Mild Influenza n=98 Participants 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.
Recurrent Visits	21 Participants	4 Participants

SECONDARY outcome

Timeframe: 0-14 days

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

Outcome measures

Measure	Moderate-to-severe Influenza n=313 Participants 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.	Mild Influenza n=98 Participants 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.
School Absenteeism	87 Participants	85 Participants

SECONDARY outcome

Timeframe: 0-14 days

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

Outcome measures

Measure	Moderate-to-severe Influenza n=313 Participants 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.	Mild Influenza n=98 Participants 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.
Work Absenteeism	71 Participants	63 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 0-14 days

Population: Outcome measure data is not required to be reported for this "other pre-specified" (not primary or secondary) outcome measure.

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

Outcome measures

Outcome data not reported

Adverse Events

Moderate-to-severe Influenza

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mild Influenza

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Suchitra Rao

University of Colorado Denver

Phone: 7207771234

Email: suchitra.rao@childrenscolorado.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place