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Trial record 19 of 21 for:    NIAID | Recruiting, Not yet recruiting, Available Studies | Influenza

Acute Respiratory Infection Consortium (ARIC)

This study is currently recruiting participants.
Verified December 2016 by Timothy Burgess, MD, MPH, Uniformed Services University of the Health Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT01021098
First Posted: November 26, 2009
Last Update Posted: December 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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
  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 Timothy Burgess, MD, MPH, Uniformed Services University of the Health Sciences:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA
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)

Estimated Enrollment: 2000
Study Start Date: November 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (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 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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021098


Contacts
Contact: Jacqueline Owens Milzman, MS 301-881-2387 jowens@idcrp.org
Contact: Chris Coles, PhD ccoles@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.c.arnold.mil@mail.mil   
Contact: Sara Echols, RN    619-532-5683    sara.j.echols.ctr@mail.mil   
Sub-Investigator: Alona Diem         
United States, Georgia
Martin Army Community Hospital, Fort Benning, GA Recruiting
Columbus, Georgia, United States, 31905
Contact: Natasha Law, MA    706-544-6583      
Contact: Arile Hadley    7065443496      
Principal Investigator: CPT Naimyah Yehudah, PA-C         
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: Sheila Taylor-Means       sheila.m.taylor-means.ctr@mail.mil   
Principal Investigator: David Stagliano, 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.g.tant.ctr@mail.mil   
Contact: Realisha Smith    757-953-6971    realisha.b.smith.ctr@mail.mil   
Sub-Investigator: Tahaniyat Lalani, MD         
United States, Washington
Madigan Army Medical Center (MAMC) Recruiting
Tacoma, Washington, United States, 98431
Contact: Susan Chambers, RN    253-968-1643    susan.e.chambers4.ctr@mail.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
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Timothy Burgess, MD, MPH, CAPT Timothy Burgess, MD, MPH, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier: NCT01021098     History of Changes
Other Study ID Numbers: IDCRP-045
First Submitted: November 10, 2009
First Posted: November 26, 2009
Last Update Posted: December 23, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Keywords provided by Timothy Burgess, MD, MPH, 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
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Infection