Acute Respiratory Infection Consortium (ARIC)

December 22, 2016 updated by: Timothy Burgess, MD, MPH, Uniformed Services University of the Health Sciences

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

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 Overview

Status

Unknown

Conditions

Detailed Description

This is an observational, longitudinal study of ARI/ILI among otherwise healthy active duty military members, retirees, as well as their spouses and dependents. An additional cohort of HIV-infected adults will also be evaluated. We will collect data from clinical findings, medical chart review, and diagnostic, virologic, and immunologic assays to describe the epidemiology and immunology of ARI/ILI. Subject recruitment will take place in both inpatient and outpatient settings of military treatment facilities (MTF) in the continental US. Additionally, subject self-referral will be encouraged through institutional review board (IRB) approved advertisements. Both adults under 65 years of age and children will be eligible for participation. Subjects will be followed for a total of up to 4 visits over a 28±7-day period. After their final visit (Day 28±7 applicable window), participants may only re-enroll into the study after 3 months have passed.

Nasal swabs, blood specimens (if consented to), buccal cytobrush samples (if consented to), and rectal swabs (in select subgroups of consenting inpatients) will be collected in order to characterize the etiologic, epidemiologic, and immunologic characteristics of ARI in the study population. In the HIV- positive cohort, additional clinical data and blood will be collected for HIV-specific factors (e.g., CD4 counts, HIV RNA levels) and for additional immunologic studies at days 0 and 28 (± 7) of the study. This is a prospective longitudinal study which will use data from clinical findings, medical chart review, and diagnostic, virologic and immunologic laboratories to describe the epidemiology and immunology of ARI/ILI.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92134
    • Georgia
      • Columbus, Georgia, United States, 31905
        • Recruiting
        • Martin Army Community Hospital, Fort Benning, GA
        • Contact:
          • Natasha Law, MA
          • Phone Number: 706-544-6583
        • Contact:
          • Arile Hadley
          • Phone Number: 7065443496
        • Principal Investigator:
          • CPT Naimyah Yehudah, PA-C
    • Maryland
      • Bethesda, Maryland, United States, 20814
    • Texas
      • San Antonio, Texas, United States, 78234
    • Virginia
      • Portsmouth, Virginia, United States, 23708
    • Washington
      • Tacoma, Washington, United States, 98431
        • Recruiting
        • Madigan Army Medical Center (MAMC)
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Mary Fairchok, MD
        • Principal Investigator:
          • Christina Schofield, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 55 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Males and females ages 17-55 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. 17 year old enrollees must be active duty and therefore considered adults per DoDI 3216.02.

Description

Natural History Study

Inclusion Criteria:

  • Between 18 and 55 years of age (inclusive), or a 17 year old military service member
  • Eligible for care in DoD facilities (DEERS eligible).
  • Have an acute influenza-like illness (ILI) or severe acute respiratory infection (SARI) for </= 7 days

Exclusion Criteria:

  • Proven Group A Streptococcal infection

Note that proven Group A Streptococcal infection will not be exclusionary IF it is proven to be a co-infection with another respiratory pathogen.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 viral respiratory pathogens in a 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/throat swabs, blood, rectal swabs) over a 28-day period. In addition, we will collect a single buccal (cheek) swab.
HIV-Positive Cohort
In addition, given a number of human immunodeficiency virus (HIV)-infected subjects who serve in the active duty force, we will also examine a subset of HIV-positive military beneficiaries as part of this consortium. 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. We will recruit subjects with ILI in both the outpatient and inpatient setting, and will serially collect biological specimens (e.g. nasal/throat swabs, blood, rectal swabs) over a 28-day period. In addition, we will collect a single buccal (cheek) swab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Develop a consortium of Department of Defense research sites capable of collecting detailed prospective clinical data, and biologic samples from active duty members and their families with ILI.
Time Frame: 7 years
7 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Develop and validate an influenza severity scale
Time Frame: 6 months
6 months
Study the relationship between health and fitness of young adults to outcomes of influenza and other respiratory viruses
Time Frame: 1 year
1 year
Examine the relationship of cell-mediated and humoral immune response to the severity of influenza and other respiratory viruses.
Time Frame: 1 year
1 year
Describe patterns of viral shedding in different influenza types and subtypes.
Time Frame: 1 year
1 year
Correlate clinical severity and cytokine/humoral response with underlying host genotype.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uniformed Services University of the Health Sciences

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Timothy H Burgess, MD, MPH, Uniformed Services University of the Health Sciences/Infectious Disease Clinical Research Program

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

November 10, 2009

First Submitted That Met QC Criteria

November 25, 2009

First Posted (Estimate)

November 26, 2009

Study Record Updates

Last Update Posted (Estimate)

December 23, 2016

Last Update Submitted That Met QC Criteria

December 22, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDCRP-045

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to directly share de-identified data with the third party Menssana Research Inc. for a substudy of an investigational device for the diagnosis of influenza. This data will include basic demographic information, flu diagnostic results, smoking status, and symptom history. This data will be de-identified and shared directly with the third party via secure file transfer. This applies only to participants recruited into the substudy at the site San Antonio Military Medical Center.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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