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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate-to-severe Influenza | Children 6 weeks to 8 years of age with influenza-like illness and one of the following:
|
| |
| Mild Influenza | Children 6 weeks to 8 years of age with influenza-like illness (ILI) without the criteria for moderate-to-severe disease (above) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respiratory nasal swab | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization | Hospitalization within 14 days of influenza infection diagnosis | 0-14 days |
| Measure | Description | Time Frame |
|---|---|---|
| ICU Admission | Admission to the intensive care unit after influenza diagnosis | 0-14 days |
| Antiviral Use | Antiviral use in children presenting to the ED or urgent care with influenza |
| Measure | Description | Time Frame |
|---|---|---|
| Injectable Influenza Vaccine (IIV) Hospitalization | Hospitalization among children who received IIV presenting to the ED or urgent care with influenza. | 0-14 days |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Edwin J Asturias, MD | University of Colorado, Denver | Principal Investigator |
| Suchitra Rao, MD | University of Colorado, Denver | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States | ||
| Children's Hospital North Campus Urgent Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19874761 | Background | 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. | |
| 17403845 | Background | 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. |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | Moderate-to-severe Influenza | Children 6 weeks to 8 years of age with influenza-like illness and one of the following:
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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Influenza positive ONLY
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| ID | Title | Description |
|---|---|---|
| BG000 | Moderate-to-severe Influenza | Children 6 weeks to 8 years of age with influenza-like illness and one of the following:
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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Subjects analyzed are ONLY influenza positive confirmed |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hospitalization | Hospitalization within 14 days of influenza infection diagnosis | Posted | Count of Participants | Participants | 0-14 days |
|
14 days since enrollment until follow up
Procedure related adverse events (nasal bleeding, nasal trauma from swab)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Moderate-to-severe Influenza | Children 6 weeks to 8 years of age with influenza-like illness and one of the following:
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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Suchitra Rao | University of Colorado Denver | 7207771234 | suchitra.rao@childrenscolorado.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2017 | Jan 13, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D010033 | Otitis Media |
| D004660 | Encephalitis |
| D005334 | Fever |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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Respiratory swab samples
|
| 0-14 days |
| Antibiotic Use | Antibiotic use in children presenting to the ED or urgent care with influenza | 0-14 days |
| Recurrent Visits | Recurrent visits to the ED or healthcare provider in children presenting to the ED or urgent care with influenza | 0-14 days |
| School Absenteeism | Absenteeism from school or daycare in patients presenting to the ED or urgent care with influenza | 0-14 days |
| Work Absenteeism | Absenteeism from work in caregivers of children presenting to the ED or urgent care with influenza | 0-14 days |
| Broomfield |
| Colorado |
| 80023 |
| United States |
| 10648764 | Background | 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. |
| 10648763 | Background | 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. |
| 16678945 | Background | 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. |
| 24676207 | Background | 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. |
| 27086364 | Background | 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. |
| 24328444 | Background | 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. |
| 35960719 | Derived | 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. |
| 32756876 | Derived | 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. |
| 31724050 | Derived | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Median |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | 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.
|
|
| Secondary | ICU Admission | Admission to the intensive care unit after influenza diagnosis | Posted | Count of Participants | Participants | 0-14 days |
|
|
|
| Secondary | Antiviral Use | Antiviral use in children presenting to the ED or urgent care with influenza | Posted | Count of Participants | Participants | 0-14 days |
|
|
|
| Secondary | Antibiotic Use | Antibiotic use in children presenting to the ED or urgent care with influenza | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 0-14 days |
|
|
|
| Secondary | School Absenteeism | Absenteeism from school or daycare in patients presenting to the ED or urgent care with influenza | Posted | Count of Participants | Participants | 0-14 days |
|
|
|
| Secondary | Work Absenteeism | Absenteeism from work in caregivers of children presenting to the ED or urgent care with influenza | Posted | Count of Participants | Participants | 0-14 days |
|
|
|
| Other Pre-specified | Injectable Influenza Vaccine (IIV) Hospitalization | Hospitalization among children who received IIV presenting to the ED or urgent care with influenza. | Outcome measure data is not required to be reported for this "other pre-specified" (not primary or secondary) outcome measure. | Posted | 0-14 days |
|
|
| 0 |
| 313 |
| 0 |
| 313 |
| 0 |
| 313 |
| EG001 | 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. | 0 | 98 | 0 | 98 | 0 | 98 |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |