InfluenzaARICNCT01021098
Acute Respiratory Infection Consortium
An observational study of Influenza, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 17 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- How many people
- 2,018 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2009to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814
Naval Medical Center, Portsmouth, VA
Portsmouth, Virginia, 23708
San Antonio Military Medical Center/Wilford Hall
San Antonio, Texas, 78234
Naval Medical Center, San Diego, CA
San Diego, California, 92134
Madigan Army Medical Center (MAMC)
Tacoma, Washington, 98431
About this study
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
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.
Read the 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
- Keywords
- influenza, illness, active-duty, virus, flu, military, Influenza-like-illnesses
- Medical subject headings
- Influenza, Human, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects enrolled in the IDCRP ARI Consortium Natural History Study
Clinical signs and symptoms,antibody titers (sera), serum cytokines and cell-mediated immunity (peripheral blood mononuclear cell activity), along with pathogen data (nasal swab/fecal swab), human leukocyte antigen (HLA) using a buccal swab, and fecal swabs to study the epidemiology, etiology , clinical characteristics and immunology of medically-attended ILI and SARI cases in this population.
Measured: 10 years
Secondary outcomes (3)
Develop and validate a patient-reported influenza outcome (Flu-PRO) instrument in patients with influenza-like illness
Internal consistency reliability of the Flu-PRO Total and Domain scores on day 1
Measured: 6 months
Impact of HIV-status on symptom severity, as measured by mean total composite score using Flu-Pro instrument, in subjects with influenza-like-illness
Mean total composite symptom scores during the ILI episode were compared by HIV status using multivariate linear models, controlling for other factors such as influenza season, age, race, and military status. Measurement tool = Flu-Pro
Measured: 1 year
Describe patterns of viral shedding by viral pathogen and pathogen subtype
Serial nasal swabs collected from patients will be used to determine the duration of viral shedding
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,018 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy H Burgess, MD, MPH, Principal investigator, Uniformed Services University of the Health Sciences/Infectious Disease Clinical Research Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021098
- Sponsor's protocol ID
- IDCRP-045
- Other IDs
- HT9404-12-2-0004
- Acronym
- ARIC
- Status last verified
- Nov 2023
- First submitted
- 10 Nov 2009
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: We plan to directly share de-identified data with the third party Menssana Research Inc. for a substudy of an investigational device for the diagnosis of influenza. This data will include basic demographic information, flu diagnostic results, smoking status, and symptom history. This data will be de-identified and shared directly with the third party via secure file transfer. This applies only to participants recruited into the substudy at the site San Antonio Military Medical Center.
Publications
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.
PubMed 33893210Deiss 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.
PubMed 26562321
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01021098
- Acronym / sponsor ID
- ARIC / IDCRP-045
- Conditions
- Influenza
- Keywords
- influenza, illness, active-duty, virus, flu, military, Influenza-like-illnesses
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,018 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Nov 2009
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 26 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 17 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of subjects enrolled in the IDCRP ARI Consortium Natural History Study
Time frame: 10 years
Clinical signs and symptoms,antibody titers (sera), serum cytokines and cell-mediated immunity (peripheral blood mononuclear cell activity), along with pathogen data (nasal swab/fecal swab), human leukocyte antigen (HLA) using a buccal swab, and fecal swabs to study the epidemiology, etiology , clinical characteristics and immunology of medically-attended ILI and SARI cases in this population.
3 secondary outcomes
Develop and validate a patient-reported influenza outcome (Flu-PRO) instrument in patients with influenza-like illness
Time frame: 6 months
Impact of HIV-status on symptom severity, as measured by mean total composite score using Flu-Pro instrument, in subjects with influenza-like-illness
Time frame: 1 year
Describe patterns of viral shedding by viral pathogen and pathogen subtype
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Derived from this study: PubMed 33893210Colombo 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.
- Derived from this study: PubMed 26562321Deiss 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.
- Individual participant dataSharing planned: Yes. We plan to directly share de-identified data with the third party Menssana Research Inc. for a substudy of an investigational device for the diagnosis of influenza. This data will include basic demographic information, flu diagnostic results, smoking status, and symptom history. This data will be de-identified and shared directly with the third party via secure file transfer. This applies only to participants recruited into the substudy at the site San Antonio Military Medical Center.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy H Burgess, MD, MPH principal investigator
Uniformed Services University of the Health Sciences/Infectious Disease Clinical Research Program
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects enrolled in the IDCRP ARI Consortium Natural History Study (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01021098, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023; AzTrials last refreshed its copy on 28 Oct 2026.