Acute Respiratory Infection Consortium (ARIC)
Tracking Information | |||||||||
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First Received Date ICMJE | November 10, 2009 | ||||||||
Last Updated Date | April 9, 2012 | ||||||||
Start Date ICMJE | November 2009 | ||||||||
Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT01021098 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Acute Respiratory Infection Consortium | ||||||||
Official Title ICMJE | 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 | ||||||||
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. |
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Detailed Description | |||||||||
Study Type ICMJE | Observational | ||||||||
Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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Biospecimen | 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) |
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Sampling Method | Probability Sample | ||||||||
Study Population | 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. |
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Condition ICMJE | Influenza | ||||||||
Intervention ICMJE | |||||||||
Study Group/Cohort (s) |
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Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 2000 | ||||||||
Estimated Completion Date | December 2013 | ||||||||
Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Natural History Study Inclusion Criteria:
Family Transmission Study Inclusion Criteria:
Exclusion Criteria for both studies:
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Gender | Both | ||||||||
Ages | up to 65 Years | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01021098 | ||||||||
Other Study ID Numbers ICMJE | IDCRP-045 | ||||||||
Has Data Monitoring Committee | No | ||||||||
Responsible Party | Maya Brown, United States Naval Medical Center, San Diego | ||||||||
Study Sponsor ICMJE | Uniformed Services University of the Health Sciences | ||||||||
Collaborators ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
Investigators ICMJE |
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Information Provided By | Uniformed Services University of the Health Sciences | ||||||||
Verification Date | April 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |