N/A
N=501
Study on the Burden of Influenza-related Hospitalizations and Emergency Room (ER) Visits in Children in Spain
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT01592799 ↗Enrolled (actual)
501
Serious AEs
—
Results posted
Jul 2018
Primary outcome: Primary: Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever — 120; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Throat swab and/or nasopharyngeal swab (Procedure); Data collection (Other)
- Age
- Pediatric
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever |
120; 11 | — |
| PRIMARY Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza |
57.27; 16.94; 89.94; 52.97; 5.52; 12.28 | — |
| SECONDARY Number of Subjects With Other Laboratory-confirmed Respiratory Viruses |
98; 47 | — |
| SECONDARY Number of Subjects With Fatal Outcomes |
0; 0 | — |
| SECONDARY Number of Subjects With Secondary Bacterial Infections |
37; 145; 11; 34; 3; 7 | — |
| SECONDARY Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status |
32; 82; 99; 288; 1; 12 | — |
| SECONDARY Number of Days of Hospitalization |
2.0; 4.4 | — |
| SECONDARY Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status |
119; 300; 9; 21; 3; 7 | — |
| SECONDARY Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status |
122; 344; 4; 1; 17; 77 | — |
| SECONDARY Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status |
130; 367; 3; 0; 41; 151 | — |
| SECONDARY Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit |
9; 30; 2; 11; 0; 1 | — |
| SECONDARY Number of Days of School Absenteeism |
6.6; 6.4 | — |
| SECONDARY Number of Days of Parent or Caregiver Time Off Work |
4.4; 4.1 | — |
| SECONDARY Number of Subjects With Household Members With Influenza-like Illness |
73; 146; 58; 224; 19; 35 | — |
| SECONDARY Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever) |
25.80; 17.45 | — |
Summary
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.
Eligibility Criteria
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 :
- Isolated fever 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.
And/or
- ARI defined as one or more of the following symptoms: sore throat, coryza, cough, breathing difficulties.
Exclusion Criteria
- Children in foster care.
Data sourced from ClinicalTrials.gov (NCT01592799). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.