Evaluation of Moderate to Severe Influenza Outcomes in Children

Influenza Clinical Trial

— M2SFlu  

Official title:

Evaluation of Moderate to Severe Influenza Disease in Children 6 Months to 8 Years in Colorado

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02979626
• Other study ID #: 16-1785
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Encephalitic Infection
• Fever
• Infection
• Influenza
• Influenza, Human
• Lower Resp Tract Infection
• Myositis
• Myositis Viral
• Otitis Media

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