View Clinical Trial (Medical Research Study)

Acute Respiratory Infection Consortium - NCT01021098-23708(Clinical Trial 445934)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  Portsmouth
State:  
VA
Zip Code: 23708
Conditions: Influenza
Purpose: Recently, the emergence and rapid global dissemination of novel swine-origin influenza A virus (H1N1) with unique epidemiologic characteristics has heightened awareness and concern of this viral pathogen, and its potential for major disruption of both civil and military stability. Although advances in medical and scientific technologies have improved our basic understanding of respiratory disease, many questions about the epidemiology and immunology of ARI remain unanswered. This study plans to initiate a multi-site, multi-disciplinary research collaboration, termed the Acute Respiratory Infection Consortium (ARIC) for the purpose of studying the etiology, epidemiology and immunology of influenza-like illness (ILI) in order to describe the natural history and risk factors for disease, as well as the characteristics of the host immune response. At the core of the ARIC is the proposed observational, longitudinal study of the Natural History Study of ILI among active duty military members, healthy retirees, and their dependents recruited from both inpatient and outpatient settings of military treatment facilities (MTF) in the continental US to be followed for a total of four (4) visits over a 28-day period. Additionally, the investigators also propose to conduct a household-based study of influenza (Family Transmission Study) in which individuals who have a laboratory-confirmed influenza illness will be recruited and enrolled along with their family members for the purpose of studying transmission of influenza within households. Taken together, these studies will establish a longitudinal cohort of ILI among active duty members and their families, as well as a repository of biological specimens relevant to the epidemiology and immunology of infection. Ultimately, these studies will serve as a solid foundation on which future investigations of ARI epidemiology, treatment and prevention can be based.
Study summary:
Criteria: Natural History Study Inclusion Criteria: - Between birth and 65 years of age. - Eligible for care in DoD facilities (DEERS eligible). - Have an influenza-like illness (ILI). Family Transmission Study Inclusion Criteria: - Between birth and 65 years of age. - Eligible for care in DoD facilities (DEERS eligible). - The primary/index case has laboratory-confirmed illness (e.g. positive for influenza by rapid influenza by rapid antigen test, PCR-based testing or other molecular diagnostic assays). - The household contains at least 3 members in residence (i.e., in the home- other family members living at least 5 nights/week for 3 weeks/month), with at least one adult > 18 years of age, and at least one child < 18 years of age. - Biologically related or otherwise qualify for DoD care, as defined by the DEERS system. - Parents or guardians agree to either: - Follow up at the MTF ID clinics for scheduled nasal swabs and diary completion/verification. - Allow study personnel to stop by their households at the subject family's convenience for swab collection and diary completion/verification. Exclusion Criteria for both studies: - Individuals with Type 1 or 2 diabetes requiring medication - Immunocompromised persons (congenital, acquired) including the following: - HIV infected individuals - Active malignancies, or received anti-neoplastic chemotherapy during the previous 2 years - All solid organ transplant recipients - Patients receiving immune modulating agents (monoclonal antibodies, glucocorticoids for > 5 days within the last month) - Individuals with chronic pulmonary disorders including chronic obstructive pulmonary disease (COPD), Cystic Fibrosis, and Severe Asthma (requiring chronic multi-drug therapy or hospitalization during the previous 6 months) - Individuals with chronic neuromuscular disease - Individuals with chronic cardiac disease - Pregnant women with a complicated or high-risk pregnancy NOTE: Normal (uncomplicated) pregnancy will not be an exclusion criteria - Individuals with severe/poorly controlled psychiatric disorders (primarily those which may impact on validity of informed consent or compliance with the study)
Study is available at: Naval Medical Center, Portsmouth, VA
Portsmouth, VA 23708
United States

Primary Contact:
Rezalina Tant
Email: rezalina.tant@med.navy.mil
Phone: 757-953-5538

Secondary Contact:
Martin Ottolini, MD
Email: mottolini@usuhs.mil
Phone: 301-295-1546
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.