Acute Respiratory Infection Consortium (ARIC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Uniformed Services University of the Health Sciences.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Maya Brown, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier:
NCT01021098
First received: November 10, 2009
Last updated: April 9, 2012
Last verified: April 2012

November 10, 2009
April 9, 2012
November 2009
December 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01021098 on ClinicalTrials.gov Archive Site
  • 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 ]
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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)

Probability Sample

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.

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 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 patients with ILI in both the outpatient and inpatient setting, and will serially collect biological specimens (e.g. nasal/oral swabs, blood, rectal swabs) over a 28-day period.
  • Family Transmission Study
    The Family Transmission Study will provide unique insight into the epidemiology of influenza within households. Information gained from this study will have important implications for future strategies in the control and prevention of influenza, and possibly other respiratory pathogens.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
December 2013
December 2013   (final data collection date for primary outcome measure)

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)
Both
up to 65 Years
Yes
Contact: Martin Ottolini, MD 301-295-1546 mottolini@usuhs.mil
Contact: Eugene Millar, PhD 301-295-1176 emillar@idcrp.org
United States
 
NCT01021098
IDCRP-045
No
Maya Brown, United States Naval Medical Center, San Diego
Uniformed Services University of the Health Sciences
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: John C Arnold, MD Naval Medical Center, San Diego/Infectious Disease Clinical Research Program
Principal Investigator: Martin Ottolini, MD Uniformed Services University of the Health Sciences
Uniformed Services University of the Health Sciences
April 2012

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