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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02979626
Other study ID # 16-1785
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 30, 2017
Est. completion date May 5, 2018

Study information

Verified date January 2021
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1478
Est. completion date May 5, 2018
Est. primary completion date May 4, 2018
Accepts healthy volunteers No
Gender All
Age group 6 Months to 8 Years
Eligibility 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 >37.8°C 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

Study Design


Intervention

Procedure:
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.

Locations

Country Name City State
United States Children's Hospital Colorado Aurora Colorado
United States Children's Hospital North Campus Urgent Care Broomfield Colorado

Sponsors (2)

Lead Sponsor Collaborator
University of Colorado, Denver GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Apr 7. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Injectable Influenza Vaccine (IIV) Hospitalization Hospitalization among children who received IIV presenting to the ED or urgent care with influenza. 0-14 days
Primary Hospitalization Hospitalization within 14 days of influenza infection diagnosis 0-14 days
Secondary ICU Admission Admission to the intensive care unit after influenza diagnosis 0-14 days
Secondary Antiviral Use Antiviral use in children presenting to the ED or urgent care with influenza 0-14 days
Secondary Antibiotic Use Antibiotic use in children presenting to the ED or urgent care with influenza 0-14 days
Secondary Recurrent Visits Recurrent visits to the ED or healthcare provider in children presenting to the ED or urgent care with influenza 0-14 days
Secondary School Absenteeism Absenteeism from school or daycare in patients presenting to the ED or urgent care with influenza 0-14 days
Secondary Work Absenteeism Absenteeism from work in caregivers of children presenting to the ED or urgent care with influenza 0-14 days
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