Acute Respiratory Infection Consortium

NCT ID: NCT01021098

Last Updated: 2023-11-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 2018 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2023-12-31

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.

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.

Conditions

Influenza

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• None

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy H Burgess, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Uniformed Services University of the Health Sciences/Infectious Disease Clinical Research Program

Locations

Naval Medical Center, San Diego, CA

San Diego, California, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

San Antonio Military Medical Center/Wilford Hall

San Antonio, Texas, United States

Naval Medical Center, Portsmouth, VA

Portsmouth, Virginia, United States

Madigan Army Medical Center (MAMC)

Tacoma, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33893210 (View on PubMed)

Deiss 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.

Reference Type: DERIVED

PMID: 26562321 (View on PubMed)

Other Identifiers

HT9404-12-2-0004

Identifier Type: OTHER

Identifier Source: secondary_id

IDCRP-045

Identifier Type: -

Identifier Source: org_study_id