Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to quantify the inpatient and ER visits burden of laboratory-confirmed influenza, and compare the clinical features, severity, complications, risk factors and socioeconomic impact of influenza in children presenting with acute respiratory illness (ARI) and/or isolated fever, with or without laboratory-confirmed influenza.
The total medical cost associated with each hospitalization or ER visit will also be calculated at the end of this study.
The study will be conducted from October, 2010, until May, 2011. Each subject will be followed-up for 21-30 days via telephone. The follow-up medical chart review will preferably be performed within 7 days after the telephone contact.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Influenza Group | Other | Children <15 years of age hospitalized for or presenting to an ER for acute ARI and/or isolated fever during the influenza season. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Throat swab and/or nasopharyngeal swab | Procedure | Samples will be tested to quantify the inpatient and ER visits burden of laboratory-confirmed influenza. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever | ARI was defined as one or more of the following symptoms: sore throat (in children greater than or equal to (≥) 3 years old), coryza (runny nose), cough, breathing difficulties. Isolated fever was defined as: oral temperature ≥37.5°C / axillary temperature ≥37.5°C / Rectal temperature ≥38°C / tympanic temperature on oral setting ≥37.5°C / tympanic temperature on rectal setting ≥38°C without an obvious cause. | Day 0 till Day 28-37 |
| Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza | Ward specific room charge and Intensive Care Unit (ICU) were computed as daily charge multiplied by the number of days. | Day 0 till Day 28-37 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Other Laboratory-confirmed Respiratory Viruses | Among the other laboratory-confirmed respiratory viruses there were:adenovirus, respiratory syncytial virus, parainfluenza virus 1, 2 and 3, metapneumovirus, bocavirus, rhinovirus or coronavirus. The outcome was assessed in subjects with an acute respiratory illness (ARI) and/or isolated fever episode. | Day 0 till Day 28-37 |
Not provided
Inclusion Criteria:
Subjects for whom the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol.
A male or female <15 years of age at the time of study entry. A subject will become ineligible on his/her 15th birthday.
Signed informed consent from the parents or guardians of the subject and signed assent from children ≥ 12 years old.
Presenting with a sudden onset clinical process comprising :
And/or
Exclusion Criteria:
• Children in foster care.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Bilbao | 48013 | Spain |
Not provided
Recruitment started in October, 2010, and last until May, 2011, or until the target sample size was enrolled.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Influenza Group | Children <15 years of age hospitalized for or presenting to an Emergency Room (ER) for Acute Respiratory Illness (ARI) and/or isolated fever during the influenza season. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Influenza Group | Children less than (<) 15 years of age hospitalized for or presenting to an ER for acute ARI and/or isolated fever during the influenza season. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever | ARI was defined as one or more of the following symptoms: sore throat (in children greater than or equal to (≥) 3 years old), coryza (runny nose), cough, breathing difficulties. Isolated fever was defined as: oral temperature ≥37.5°C / axillary temperature ≥37.5°C / Rectal temperature ≥38°C / tympanic temperature on oral setting ≥37.5°C / tympanic temperature on rectal setting ≥38°C without an obvious cause. | The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available. | Posted | Count of Participants | Participants | Day 0 till Day 28-37 |
|
No solicited or unsolicited adverse events were collected during this study. No SAEs or fatal events were recorded during this study.
Serious and non-serious adverse events were not planned to be assessed as part of this study protocol.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Influenza Group | Children <15 years of age hospitalized for or presenting to an ER for acute ARI and/or isolated fever during the influenza season. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Data collection | Other | Log Sheet will be used to collected data on a monthly basis for the following age groups: < 6 months; 6-23 months; 24-59 months; > 5 years. |
|
| Number of Subjects With Fatal Outcomes | Deaths from ARI and/or fever episodes by laboratory-confirmed influenza status were assessed. | Day 0 till Day 28-37 |
| Number of Subjects With Secondary Bacterial Infections | The outcome assessed the various complications by laboratory-confirmed influenza status. | Day 0 till Day 28-37 |
| Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | Risk factors were classified as pre-existing conditions, breast-feeding status and day-care status. | Day 0 till Day 28-37 |
| Number of Days of Hospitalization | The outcomes was assessed in subjects with laboratory-confirmed influenza status | Day 0 till Day 28-37 (between October 2010 until May 2011) |
| Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics. | Day 0 till Day 28-37 |
| Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics. | Day 0 till Day 28-37 |
| Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics. | Day 0 till Day 28-37 |
| Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit | ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics. | Day 0 till Day 28-37 |
| Number of Days of School Absenteeism | School absenteeism was assessed among patients during the follow-up period by laboratory-confirmed influenza status. | Day 0 till Day 28-37 |
| Number of Days of Parent or Caregiver Time Off Work | This outcome assessed absenteeism among caregivers to provide patient care during the follow-up period by laboratory-confirmed influenza status. | Day 0 till Day 28-37 |
| Number of Subjects With Household Members With Influenza-like Illness | This outcome assessed the number of cases with household contacts presenting influenza like illness symptoms during the follow-up period by laboratory-confirmed influenza status. | Day 0 till Day 28-37 |
| Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever) | This outcome assessed the proportion of influenza like illness (ILI) among household members of children < 15 years with and without laboratory-confirmed influenza. | Day 0 till Day 28-37 |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Children <15 years of age hospitalized for or presenting to an ER for ARI and/or isolated fever during the influenza season.
|
|
| Primary | Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza | Ward specific room charge and Intensive Care Unit (ICU) were computed as daily charge multiplied by the number of days. | The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available and who were hospitalized or visited an emergency room. | Posted | Mean | Standard Deviation | Euros | Day 0 till Day 28-37 |
|
|
|
| Secondary | Number of Subjects With Other Laboratory-confirmed Respiratory Viruses | Among the other laboratory-confirmed respiratory viruses there were:adenovirus, respiratory syncytial virus, parainfluenza virus 1, 2 and 3, metapneumovirus, bocavirus, rhinovirus or coronavirus. The outcome was assessed in subjects with an acute respiratory illness (ARI) and/or isolated fever episode. | The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available. | Posted | Count of Participants | Participants | Day 0 till Day 28-37 |
|
|
|
| Secondary | Number of Subjects With Fatal Outcomes | Deaths from ARI and/or fever episodes by laboratory-confirmed influenza status were assessed. | The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available. | Posted | Count of Participants | Participants | Day 0 till Day 28-37 |
|
|
|
| Secondary | Number of Subjects With Secondary Bacterial Infections | The outcome assessed the various complications by laboratory-confirmed influenza status. | The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available. | Posted | Count of Participants | Participants | Day 0 till Day 28-37 |
|
|
|
| Secondary | Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status | Risk factors were classified as pre-existing conditions, breast-feeding status and day-care status. | The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available. | Posted | Count of Participants | Participants | Day 0 till Day 28-37 |
|
|
|
| Secondary | Number of Days of Hospitalization | The outcomes was assessed in subjects with laboratory-confirmed influenza status | The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available. | Posted | Mean | Standard Deviation | Days | Day 0 till Day 28-37 (between October 2010 until May 2011) |
|
|
|
| Secondary | Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics. | The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available. | Posted | Count of Participants | Participants | Day 0 till Day 28-37 |
|
|
|
| Secondary | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics. | The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available. | Posted | Count of Participants | Participants | Day 0 till Day 28-37 |
|
|
|
| Secondary | Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status | ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics. | The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available. | Posted | Count of Participants | Participants | Day 0 till Day 28-37 |
|
|
|
| Secondary | Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit | ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics. | The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available. | Posted | Count of Participants | Participants | Day 0 till Day 28-37 |
|
|
|
| Secondary | Number of Days of School Absenteeism | School absenteeism was assessed among patients during the follow-up period by laboratory-confirmed influenza status. | The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available. | Posted | Mean | Standard Deviation | Days | Day 0 till Day 28-37 |
|
|
|
| Secondary | Number of Days of Parent or Caregiver Time Off Work | This outcome assessed absenteeism among caregivers to provide patient care during the follow-up period by laboratory-confirmed influenza status. | The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available. | Posted | Mean | Standard Deviation | Days | Day 0 till Day 28-37 |
|
|
|
| Secondary | Number of Subjects With Household Members With Influenza-like Illness | This outcome assessed the number of cases with household contacts presenting influenza like illness symptoms during the follow-up period by laboratory-confirmed influenza status. | The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available. | Posted | Number | Household members | Day 0 till Day 28-37 |
|
|
|
| Secondary | Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever) | This outcome assessed the proportion of influenza like illness (ILI) among household members of children < 15 years with and without laboratory-confirmed influenza. | The analysis was performed on the according-to-protocol (ATP) cohort for analysis, which included all evaluable subjects (i.e. those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning endpoint measures were available. | Posted | Number | 95% Confidence Interval | Percentage of household members | Day 0 till Day 28-37 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Title | Measurements |
|---|---|
|
| Total for diagnostics |
|
| Prescribed medication [given in the hospital] |
|
| Prescribed medication |
|
| Non-prescribed medication |
|
| Total for treatments |
|
| Ward specific room charge |
|
| ICU |
|
| Total for inpatient charge |
|
| ER visit |
|
| Others |
|
| Primary influenza viral pneumonia |
|
| Bronchiolitis |
|
| Acute Otitis Media |
|
| Myositis |
|
| Pericarditis |
|
| Conjunctivitis |
|
| Prematurity (<36 weeks gestation) |
|
| Chronic pneumopathy (including asthma) |
|
| Cardiovascular disease |
|
| Neuromuscular diseases |
|
| Other |
|
| Breast fed |
|
| Not breast fed |
|
| Breast feeding status not known (>2 years old) |
|
| In day-care attendance |
|
| Not in day-care attendance |
|
| Not known if in day-care attendance (>5 years old) |
|
| Cough suppressants |
|
| Antihistamines |
|
| Pain medication |
|
| Antipyretics |
|
| Mucolytics |
|
| Other medication |
|
| Antibiotics |
|
| Cough suppressants |
|
| Pain medication |
|
| Antipyretics |
|
| Mucolytics |
|
| Other medication |
|
| Antibiotics |
|
| Cough suppressants |
|
| Antihistamines |
|
| Pain medication |
|
| Antipyretics |
|
| Mucolytics |
|
| Other medication |
|
| Antihistamines |
|
| Pain medication |
|
| Antipyretics |
|
| Mucolytics |
|
| Other medication |
|
| 1-2 household members with ARI/fever |
|
| 3-4 household members with ARI/fever |
|
| >4 household members with ARI/fever |
|
| Missing confirmed |
|