Clinical trial NCT01021098: Acute Respiratory Infection Consortium
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Influenza
Keywords: influenza
illness
active-duty
virus
flu
military
Influenza-like-illnesses
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2009-11-26
Enrollment: 2018
Sex: ALL
Minimum age (years): 17
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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 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

Primary outcomes:
measure: Number of subjects enrolled in the IDCRP ARI Consortium Natural History Study
timeFrame: 10 years
Secondary outcomes:
measure: Develop and validate a patient-reported influenza outcome (Flu-PRO) instrument in patients with influenza-like illness
timeFrame: 6 months
measure: Impact of HIV-status on symptom severity, as measured by mean total composite score using Flu-Pro instrument, in subjects with influenza-like-illness
timeFrame: 1 year
measure: Describe patterns of viral shedding by viral pathogen and pathogen subtype
timeFrame: 1 year
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center, San Diego, CA
state: California
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: San Antonio
country: United States
facility: San Antonio Military Medical Center/Wilford Hall
state: Texas
city: Portsmouth
country: United States
facility: Naval Medical Center, Portsmouth, VA
state: Virginia
city: Tacoma
country: United States
facility: Madigan Army Medical Center (MAMC)
state: Washington
Study officials:
affiliation: Uniformed Services University of the Health Sciences/Infectious Disease Clinical Research Program
name: Timothy H Burgess, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.