Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT01021098 |
| Other study ID # |
IDCRP-045 |
| Secondary ID |
HT9404-12-2-0004 |
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 2009 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
November 2023 |
| Source |
Henry M. Jackson Foundation for the Advancement of Military Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
