Acute Respiratory Infection Consortium
ARIC
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
2 other identifiers
observational
2,018
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2009
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 10, 2009
CompletedFirst Posted
Study publicly available on registry
November 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedNovember 24, 2023
November 1, 2023
14.1 years
November 10, 2009
November 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of subjects enrolled in the IDCRP ARI Consortium Natural History Study
Clinical signs and symptoms,antibody titers (sera), serum cytokines and cell-mediated immunity (peripheral blood mononuclear cell activity), along with pathogen data (nasal swab/fecal swab), human leukocyte antigen (HLA) using a buccal swab, and fecal swabs to study the epidemiology, etiology , clinical characteristics and immunology of medically-attended ILI and SARI cases in this population.
10 years
Secondary Outcomes (3)
Develop and validate a patient-reported influenza outcome (Flu-PRO) instrument in patients with influenza-like illness
6 months
Impact of HIV-status on symptom severity, as measured by mean total composite score using Flu-Pro instrument, in subjects with influenza-like-illness
1 year
Describe patterns of viral shedding by viral pathogen and pathogen subtype
1 year
Study Arms (2)
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.
Eligibility Criteria
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.
You may qualify if:
- Between 18 and 55 years of age (inclusive), or a 17 year old military service member
- Eligible for care in Department of Defense (DOD) facilities (DEERS eligible).
- Have an acute influenza-like illness (ILI) or severe acute respiratory infection (SARI) for \</= 7 days
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Naval Medical Center, San Diego, CA
San Diego, California, 92134, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814, United States
San Antonio Military Medical Center/Wilford Hall
San Antonio, Texas, 78234, United States
Naval Medical Center, Portsmouth, VA
Portsmouth, Virginia, 23708, United States
Madigan Army Medical Center (MAMC)
Tacoma, Washington, 98431, United States
Related Publications (2)
Colombo RE, Schofield C, Richard SA, Fairchok M, Chen WJ, Danaher PJ, Lalani TN, Ridore M, Maves RC, Arnold JC, Ganesan A, Agan B, Millar EV, Coles C, Burgess TH. Effects of human immunodeficiency virus status on symptom severity in influenza-like illness in an otherwise healthy adult outpatient cohort. J Investig Med. 2021 Aug;69(6):1230-1237. doi: 10.1136/jim-2020-001694. Epub 2021 Apr 23.
PMID: 33893210DERIVEDDeiss RG, Arnold JC, Chen WJ, Echols S, Fairchok MP, Schofield C, Danaher PJ, McDonough E, Ridore M, Mor D, Burgess TH, Millar EV. Vaccine-associated reduction in symptom severity among patients with influenza A/H3N2 disease. Vaccine. 2015 Dec 16;33(51):7160-7167. doi: 10.1016/j.vaccine.2015.11.004. Epub 2015 Nov 10.
PMID: 26562321DERIVED
Biospecimen
nasal 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)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy H Burgess, MD, MPH
Uniformed Services University of the Health Sciences/Infectious Disease Clinical Research Program
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2009
First Posted
November 26, 2009
Study Start
November 1, 2009
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
November 24, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- 2018 to 2020
- Access Criteria
- Researchers are required to submit a formal request describing the research questions of interest and protocol for review. If the request is approved, IDCRP investigators must be listed on any research publications resulting from research using the study data.
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.