Clinical IGSP-CHOP Boston

NCT00428831 | Completed

• 1 other identifier: 06-0096
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Influenza

Keywords

influenza, genomic data, nasopharyngeal aspirate

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Rates of clinical features and of specific viral strains in the pediatric and adult populations.

  Enrollment and Follow up phone call.

Study Arms (1)

1

Patients with respiratory illnesses.

Eligibility Criteria

• Age: 30 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Will recruit patients of both genders and of any health status. Will be recruited at Children's Hospital Boston and at Beth Israel Deaconess Medical Center. At Children's Hospital, patients 30 days to 5 years of age will be recruited; at Beth Israel Deaconess Medical Center patients of any age will be eligible.

You may qualify if:

• For pediatric population: Age of patient: 30 days - 5 years; for adult population: any age
• Illness onset within past 5 days
• 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.
• Patient or parent/guardian is able to give informed consent

You may not qualify if:

• Pediatric patient or non-verbal adult is not accompanied by a caregiver
• Participant/caregiver cannot be reached by phone in 7-10 days
• 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)

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

Children's Hospital Boston - Infectious Diseases

Boston, Massachusetts, 02115-5711, United States

Location

Beth Israel Deaconess Medical Center - Medicine - Infectious Disease

Boston, Massachusetts, 02215-5400, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2007
• First Posted: January 30, 2007
• Study Start: February 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: December 20, 2013

Record last verified: 2008-09

Locations

US (2)