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Clinical IGSP-CHOP Boston

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00428831
First received: January 26, 2007
Last updated: December 19, 2013
Last verified: September 2008
  Purpose

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.


Condition
Influenza

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Correlates to Influenza Genomic Data

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • 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. [ Time Frame: Enrollment and Follow up phone call. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rates of clinical features and of specific viral strains in the pediatric and adult populations. [ Time Frame: Enrollment and Follow up phone call. ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: February 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with respiratory illnesses.

Detailed Description:

There is evidence that the pediatric population, in particular, may play an essential role in influenza transmission. One recent study showed that children between the ages of 3 and 4 years were consistently the first population group to be affected by influenza illness over several winter seasons. In addition, influenza illness in children less than 5 years of age was the strongest predictor of mortality among adults. Collecting samples from adults as well as children in the pre-school age group would enable researchers to further examine the specific role this population plays in the evolution of influenza virus lineages and the development of dominant strains. In this prospective observational study, the researchers are therefore proposing to collect samples from pediatric patients at Children's Hospital and from adults at Beth Israel Deaconess Medical Center. This will enable the researchers to compare the clinical manifestations resulting from infection by similar strains and to examine differences in the genomic sequences of the viruses between the two population groups. The primary objective of this study is to conduct a pilot study to explore correlations between influenza viral strains and clinical characteristics of infected patients, including vaccination status, organ system involvement, and disease severity. With regard to outcome measures, the researchers will determine rates of clinical features associated with specific viral strains. The clinical characteristics the researchers will examine are vaccination status, illness symptoms (presence of fever, cough, runny nose/ stuffy nose, headache, myalgia, fatigue), initial O2 saturation, treatment with antibiotics or antivirals, hospitalization, daycare or kindergarten attendance, exposure to elderly persons, and length of illness. The secondary study objective is to conduct a pilot study to compare the influenza genomic sequences and clinical data from pediatric and adult patients infected with influenza and to explore potential viral transmission patterns between these two populations. With regard to the outcome measures, the researchers will determine rates of clinical features and of specific viral strains in the pediatric and adult populations. The clinical characteristics the researchers will examine are the same as in the primary objective. The researchers will also identify any temporal patterns in the infections caused by specific viral strains in the two groups. Specifically, the researchers will examine whether any viral strains first emerge in the pediatric population prior to infecting the adult group. A total of 500 patients with respiratory illnesses 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. The researchers will recruit patients of both genders and of any health status. Respiratory samples and clinical information will be collected from each participant. It is hoped that this study will help further the researchers' understanding of how influenza viruses evolve, spread, and cause disease. In the future, this may help in the development of more effective vaccines and prevention measures, as well as treatments for people infected with influenza.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428831

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center - Medicine - Infectious Disease
Boston, Massachusetts, United States, 02215-5400
Children's Hospital Boston - Infectious Diseases
Boston, Massachusetts, United States, 02115-5711
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00428831     History of Changes
Other Study ID Numbers: 06-0096
Study First Received: January 26, 2007
Last Updated: December 19, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
influenza, genomic data, nasopharyngeal aspirate

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 19, 2014