NCT02979626

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,478

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 30, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2018

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2018

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

February 4, 2021

Completed
Last Updated

February 4, 2021

Status Verified

January 1, 2021

Enrollment Period

1.3 years

First QC Date

November 29, 2016

Results QC Date

September 3, 2019

Last Update Submit

January 15, 2021

Conditions

InfluenzaOtitis MediaLower Resp Tract InfectionEncephalitic InfectionMyositis ViralFever

Keywords

hospitalizationintensive care unitschool absenteeismwork absenteeism

Outcome Measures

Primary Outcomes (1)

  • Hospitalization

    Hospitalization within 14 days of influenza infection diagnosis

    0-14 days

Secondary Outcomes (6)

  • ICU Admission

    0-14 days

  • Antiviral Use

    0-14 days

  • Antibiotic Use

    0-14 days

  • Recurrent Visits

    0-14 days

  • School Absenteeism

    0-14 days

  • +1 more secondary outcomes

Other Outcomes (1)

  • Injectable Influenza Vaccine (IIV) Hospitalization

    0-14 days

Study Arms (2)

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)

Procedure: Respiratory nasal swab

Mild Influenza

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

Procedure: Respiratory nasal swab

Interventions

Respiratory nasal swabPROCEDURE

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.

Also known as: Nasal swab
Mild InfluenzaModerate-to-severe Influenza

Eligibility Criteria

Age6 Months - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children 6 months to 8 years of age and younger seeking evaluation and management of influenza-like illness (ILI) at any of the study sites will be eligible for participation in the study. The study will commence during the influenza season as determined by the department of microbiology and epidemiology at CHCO (the influenza season commences when there are 3 positive influenza PCR tests within a week), approximately from December 1, 2016 to April 30, 2017.

You may qualify if:

  • 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

You may not qualify if:

  • Respiratory symptom duration \> 14 days
  • Nurse only visit
  • Enrollment in the study within prior 14 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Children's Hospital North Campus Urgent Care

Broomfield, Colorado, 80023, United States

Location

Related Publications (11)

  • Wilkes JJ, Leckerman KH, Coffin SE, Keren R, Metjian TA, Hodinka RL, Zaoutis TE. Use of antibiotics in children hospitalized with community-acquired, laboratory-confirmed influenza. J Pediatr. 2009 Mar;154(3):447-9. doi: 10.1016/j.jpeds.2008.09.026.

    PMID: 19874761BACKGROUND

  • Coffin SE, Zaoutis TE, Rosenquist AB, Heydon K, Herrera G, Bridges CB, Watson B, Localio R, Hodinka RL, Keren R. Incidence, complications, and risk factors for prolonged stay in children hospitalized with community-acquired influenza. Pediatrics. 2007 Apr;119(4):740-8. doi: 10.1542/peds.2006-2679.

    PMID: 17403845BACKGROUND

  • Izurieta HS, Thompson WW, Kramarz P, Shay DK, Davis RL, DeStefano F, Black S, Shinefield H, Fukuda K. Influenza and the rates of hospitalization for respiratory disease among infants and young children. N Engl J Med. 2000 Jan 27;342(4):232-9. doi: 10.1056/NEJM200001273420402.

    PMID: 10648764BACKGROUND

  • Neuzil KM, Mellen BG, Wright PF, Mitchel EF Jr, Griffin MR. The effect of influenza on hospitalizations, outpatient visits, and courses of antibiotics in children. N Engl J Med. 2000 Jan 27;342(4):225-31. doi: 10.1056/NEJM200001273420401.

    PMID: 10648763BACKGROUND

  • Salo H, Kilpi T, Sintonen H, Linna M, Peltola V, Heikkinen T. Cost-effectiveness of influenza vaccination of healthy children. Vaccine. 2006 Jun 5;24(23):4934-41. doi: 10.1016/j.vaccine.2006.03.057. Epub 2006 Apr 7.

    PMID: 16678945BACKGROUND

  • Ferdinands JM, Olsho LE, Agan AA, Bhat N, Sullivan RM, Hall M, Mourani PM, Thompson M, Randolph AG; Pediatric Acute Lung Injury and Sepsis Investigators (PALISI) Network. Effectiveness of influenza vaccine against life-threatening RT-PCR-confirmed influenza illness in US children, 2010-2012. J Infect Dis. 2014 Sep 1;210(5):674-83. doi: 10.1093/infdis/jiu185. Epub 2014 Mar 26.

    PMID: 24676207BACKGROUND

  • Heikkinen T, Silvennoinen H, Heinonen S, Vuorinen T. Clinical and socioeconomic impact of moderate-to-severe versus mild influenza in children. Eur J Clin Microbiol Infect Dis. 2016 Jul;35(7):1107-13. doi: 10.1007/s10096-016-2641-9. Epub 2016 Apr 16.

    PMID: 27086364BACKGROUND

  • Jain VK, Rivera L, Zaman K, Espos RA Jr, Sirivichayakul C, Quiambao BP, Rivera-Medina DM, Kerdpanich P, Ceyhan M, Dinleyici EC, Cravioto A, Yunus M, Chanthavanich P, Limkittikul K, Kurugol Z, Alhan E, Caplanusi A, Durviaux S, Boutet P, Ofori-Anyinam O, Chandrasekaran V, Dbaibo G, Innis BL. Vaccine for prevention of mild and moderate-to-severe influenza in children. N Engl J Med. 2013 Dec 26;369(26):2481-91. doi: 10.1056/NEJMoa1215817. Epub 2013 Dec 11.

    PMID: 24328444BACKGROUND

  • Rao S, Moss A, Lamb M, Innis BL, Asturias EJ. Vital sign predictors of severe influenza among children in an emergent care setting. PLoS One. 2022 Aug 12;17(8):e0272029. doi: 10.1371/journal.pone.0272029. eCollection 2022.

    PMID: 35960719DERIVED

  • Rao S, Moss A, Lamb MM, Asturias EJ. Evaluation of Influenza Vaccine Effectiveness Among Young Children Receiving Consecutive Versus Nonconsecutive Vaccination During Influenza A(H3N2)-Predominant Seasons. J Pediatric Infect Dis Soc. 2021 Apr 3;10(3):359-362. doi: 10.1093/jpids/piaa080.

    PMID: 32756876DERIVED

  • Rao S, Yanni E, Moss A, Lamb MM, Schuind A, Bekkat-Berkani R, Innis BL, Cotter J, Mistry RD, Asturias EJ. Evaluation of a New Clinical Endpoint for Moderate to Severe Influenza Disease in Children: A Prospective Cohort Study. J Pediatric Infect Dis Soc. 2020 Sep 17;9(4):460-467. doi: 10.1093/jpids/piz075.

    PMID: 31724050DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Respiratory swab samples

MeSH Terms

Conditions

Influenza, HumanOtitis MediaEncephalitisFever

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesOtitisEar DiseasesOtorhinolaryngologic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Suchitra Rao
Organization
University of Colorado Denver
suchitra.rao@childrenscolorado.org
7207771234

Study Officials

  • Edwin J Asturias, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

  • Suchitra Rao, MD

    University of Colorado, Denver

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 1, 2016

Study Start

January 30, 2017

Primary Completion

May 4, 2018

Study Completion

May 5, 2018

Last Updated

February 4, 2021

Results First Posted

February 4, 2021

Record last verified: 2021-01

Locations

US(2)