Influenza Clinical Trial
Official title:
Clinical Correlates to Influenza Genomic Data
The main purpose of this study is to look at relationships between types of flu viruses and characteristics of infected patients, including vaccination status, organ system involvement, and disease severity. In this study, 500 patients with respiratory illnesses will have nose/throat fluid samples collected. At Children's Hospital Boston, patients 30 days to 5 years of age will be recruited; at Beth Israel Deaconess Medical Center, patients of any age will be eligible. The researchers will compare the symptoms of infection by similar flu virus types and look at differences in the flu virus types between the 2 age groups of patients. The researchers will also look at whether any flu virus types first show up in the children prior to infecting the adults. Hopefully this study will improve understanding of how flu viruses develop, spread, and cause disease. This information may help the development of more effective flu vaccines, prevention measures, and treatments.
Status | Completed |
Enrollment | 500 |
Est. completion date | September 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. For pediatric population: Age of patient: 30 days - 5 years; for adult population: any age 2. Illness onset within past 5 days 3. Symptoms of fever (>=38°) plus one or more of the following: cough, runny nose, congestion, or sneezing (twice or more within one day). These symptoms must be present at the time of presentation to the emergency department (ED) or admission to the hospital. 4. Patient or parent/guardian is able to give informed consent Exclusion Criteria: 1. Pediatric patient or non-verbal adult is not accompanied by a caregiver 2. Participant/caregiver cannot be reached by phone in 7-10 days 3. Patient has a condition that can compromise respiratory function or the handling of respiratory secretions (e.g., severe cognitive dysfunction, spinal cord injuries, or other neuromuscular disorders) |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center - Medicine - Infectious Disease | Boston | Massachusetts |
United States | Children's Hospital Boston - Infectious Diseases | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient's length of illness, symptoms, medication use, influenza vaccination status, initial O2 saturation, hospitalization, daycare or kindergarten attendance, exposure to elderly persons, and length of illness. | Enrollment and Follow up phone call. | No | |
Secondary | Rates of clinical features and of specific viral strains in the pediatric and adult populations. | Enrollment and Follow up phone call. | No |
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