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Acute Respiratory Infection Consortium (ARIC)

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2016 by Timothy Burgess, MD, MPH, Uniformed Services University of the Health Sciences
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Timothy Burgess, MD, MPH, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier:
NCT01021098
First received: November 10, 2009
Last updated: December 22, 2016
Last verified: December 2016
November 10, 2009
December 22, 2016
November 2009
December 2017   (Final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT01021098 on ClinicalTrials.gov Archive Site
  • Develop and validate an influenza severity scale [ Time Frame: 6 months ]
  • Study the relationship between health and fitness of young adults to outcomes of influenza and other respiratory viruses [ Time Frame: 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 ]
  • Describe patterns of viral shedding in different influenza types and subtypes. [ Time Frame: 1 year ]
  • Correlate clinical severity and cytokine/humoral response with underlying host genotype. [ Time Frame: 1 year ]
Same as current
Not Provided
Not Provided
 
Acute Respiratory Infection Consortium
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
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)
Probability Sample
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.
Influenza
Not Provided
  • 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.
Deiss RG, Arnold JC, Chen WJ, Echols S, Fairchok MP, Schofield C, Danaher PJ, McDonough E, Ridoré 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):7160-7. doi: 10.1016/j.vaccine.2015.11.004. Epub 2015 Nov 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
December 2018
December 2017   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
17 Years to 55 Years   (Child, Adult)
Yes
Contact: Jacqueline Owens Milzman, MS 301-881-2387 jowens@idcrp.org
Contact: Chris Coles, PhD ccoles@idcrp.org
United States
 
 
NCT01021098
IDCRP-045
No
Not Provided
Yes
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.
Timothy Burgess, MD, MPH, Uniformed Services University of the Health Sciences
Uniformed Services University of the Health Sciences
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Timothy H Burgess, MD, MPH Uniformed Services University of the Health Sciences/Infectious Disease Clinical Research Program
Uniformed Services University of the Health Sciences
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP