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Acute Respiratory Infection Consortium (ARIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Uniformed Services University of the Health Sciences
Sponsor:
Collaborator:
Information provided by (Responsible Party):
John Arnold, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier:
NCT01021098
First received: November 10, 2009
Last updated: November 20, 2014
Last verified: November 2014
  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.


Condition
Influenza

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-center Military Consortium for Clinical Research Into the Natural History, Host Response, and Potential Therapy of Acute Respiratory Infection in Military Members and Their Families

Resource links provided by NLM:


Further study details as provided by Uniformed Services University of the Health Sciences:

Primary Outcome Measures:
  • Develop a consortium of DoD research sites capable of collecting detailed prospective clinical data, and biologic samples from active duty members and their families with ILI. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Develop and validate an influenza severity scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Study the relationship between health and fitness of young adults to outcomes of influenza and other respiratory viruses [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Examine the relationship of cell-mediated and humoral immune response to the severity of influenza and other respiratory viruses. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Describe patterns of viral shedding in different influenza types and subtypes. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Correlate clinical severity and cytokine/humoral response with underlying host genotype. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

nasopharyngeal swabs with storage of multiple harvested (expanded) first generation viral isolates (all must opt in); buccal swab storage (may opt out) rectal swab storage (may opt out) serum storage (may opt out)


Estimated Enrollment: 2000
Study Start Date: November 2009
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Natural History Study
The core Natural History Study of ILI is an observational, longitudinal cohort study using data from clinical findings, medical chart review, and diagnostic, virologic and immunologic laboratories to describe the epidemiology and immunology of ILI. This study aims to describe the clinical history of influenza and other predominant viral respiratory pathogens in an otherwise healthy population of US military active duty members and their dependents. The primary focus will be the etiology, natural history and immunology of ILI in otherwise healthy adults and children. We will recruit subjects with ILI in both the outpatient and inpatient setting, and will serially collect biological specimens (e.g. nasal/OP swabs, blood, rectal swabs) over a 28-day period. In addition, we will collect a single buccal (cheek) swab.
HIV Positive Cohort
An additional objective of the study will be to descriptively examine the clinical and laboratory characteristics of ILI events among HIV-infected persons using the military's substantial experience in following a stable HIV-infected population. Information on prior medical conditions and/or hospitalizations and immunization history will be collected via medical chart review. Information on risk factors for ILI will be ascertained through interview-administered questionnaires.

  Eligibility

Ages Eligible for Study:   up to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Males and females of all ages and of military (including active duty enlisted and active duty officers from all branches of service), healthy retirees, and their dependents (spouses and children) presenting to inpatient/outpatient facilities with ILI will be eligible for participation. At select sites, military members and their family members (healthy spouses and children) may be eligible for participation in the study of household transmission of influenza. All children, regardless of study site, will be excluded from the direct collection of blood specimens for research purposes alone. Only discard blood will be collected from children and no additional needle sticks will occur in children. Blood will only be collected from children if indicated by the primary care physician.

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)
  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: NCT01021098

Contacts
Contact: Michelande Ridore 301-816-8452 mridore@idcrp.org
Contact: Eugene Millar, PhD 301-816-8451 emillar@idcrp.org

Locations
United States, California
Naval Medical Center, San Diego, CA Recruiting
San Diego, California, United States, 92134
Contact: John C Arnold, MD    619-532-7452    john.arnold@med.navy.mil   
Contact: Sara Echols, RN    619-532-5683    sara.echols@med.navy.mil   
Sub-Investigator: Alona Mask         
United States, Georgia
Martin Army Community Hospital/Winder Troop Medical Clinic Not yet recruiting
Fort Benning, Georgia, United States, 31905
Contact: Natasha Law, MS    706-544-3361    natasha.n.law.ctr@us.army.mil   
Contact: Jeffrey Lanier    706-544-4112    jeffrey.lanier@us.arm   
Principal Investigator: Jeffrey Lanier, MD         
United States, Maryland
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20814
Contact: Heather Burris    301-295-5542    heather.h.burris.ctr@mail.mil   
Contact: Colin Dawkins    301-295-0724    colin.t.dawkins.ctr@mail.mil   
Principal Investigator: Michael Rajnik, MD         
Sub-Investigator: Anuradha Ganesan, MD         
United States, Texas
San Antonio Military Medical Center/Wilford Hall Recruiting
San Antonio, Texas, United States, 78234
Contact: Charlotte Rhodes    210-916-5570    charlotte.e.rhodes.ctr@mail.mil   
Contact: Joanne Holloway    210-808-2335    joanne.p.holloway.ctr@mail.mil   
Principal Investigator: Patrick Danaher, MD         
United States, Virginia
Naval Medical Center, Portsmouth, VA Recruiting
Portsmouth, Virginia, United States, 23708
Contact: Rezalina Tant    757-953-5603    rezalina.tant.ctr@med.navy.mil   
Contact: Realisha Smith    757-953-6971    realisha.smith.ctr@med.navy.mil   
Sub-Investigator: Tahaniyat Lalani, MD         
Principal Investigator: Karl Kronmann, MD         
United States, Washington
Madigan Army Medical Center (MAMC) Recruiting
Tacoma, Washington, United States, 98431
Contact: Susan Chambers, RN    253-968-1643    susan.chambers@us.army.mil   
Contact: Debra Angell, CCRP    253-968-4596    debra.a.angell.ctr@mail.mil   
Sub-Investigator: Mary Fairchok, MD         
Principal Investigator: Christina Schofield, MD         
Sponsors and Collaborators
Uniformed Services University of the Health Sciences
Investigators
Principal Investigator: John C Arnold, MD Naval Medical Center, San Diego/Infectious Disease Clinical Research Program
  More Information

No publications provided

Responsible Party: John Arnold, CDR John Arnold, MD, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT01021098     History of Changes
Other Study ID Numbers: IDCRP-045
Study First Received: November 10, 2009
Last Updated: November 20, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Uniformed Services University of the Health Sciences:
influenza
illness
active-duty
virus
flu
military
Influenza-like-illnesses

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

ClinicalTrials.gov processed this record on November 25, 2014