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Acute Respiratory Infection Consortium (ARIC)

2016年12月22日更新者：Timothy Burgess, MD, MPH、Uniformed Services University of the Health Sciences

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.

調査の概要

状態

わからない

条件

インフルエンザ

詳細な説明

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.

研究の種類

観察的

入学 (予想される)

2000

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

アメリカ
- California
  - San Diego、California、アメリカ、92134
    - 募集
    - Naval Medical Center, San Diego, CA
    - コンタクト：
      
      John C Arnold, MD
      
      電話番号：619-532-7452
      
      メール：john.c.arnold.mil@mail.mil
    - コンタクト：
      
      Sara Echols, RN
      
      電話番号：619-532-5683
      
      メール：sara.j.echols.ctr@mail.mil
    - 副調査官：
      
      Alona Diem
- Georgia
  - Columbus、Georgia、アメリカ、31905
    - 募集
    - Martin Army Community Hospital, Fort Benning, GA
    - コンタクト：
      
      Natasha Law, MA
      
      電話番号：706-544-6583
    - コンタクト：
      
      Arile Hadley
      
      電話番号：7065443496
    - 主任研究者：
      
      CPT Naimyah Yehudah, PA-C
- Maryland
  - Bethesda、Maryland、アメリカ、20814
    - 募集
    - Walter Reed National Military Medical Center
    - コンタクト：
      
      Heather Burris
      
      電話番号：301-295-5542
      
      メール：heather.h.burris.ctr@mail.mil
    - コンタクト：
      
      Sheila Taylor-Means
      
      メール：sheila.m.taylor-means.ctr@mail.mil
    - 主任研究者：
      
      David Stagliano, MD
    - 副調査官：
      
      Anuradha Ganesan, MD
- Texas
  - San Antonio、Texas、アメリカ、78234
    - 募集
    - San Antonio Military Medical Center/Wilford Hall
    - コンタクト：
      
      Charlotte Rhodes
      
      電話番号：210-916-5570
      
      メール：charlotte.e.rhodes.ctr@mail.mil
    - コンタクト：
      
      Joanne Holloway
      
      電話番号：210-808-2335
      
      メール：joanne.p.holloway.ctr@mail.mil
    - 主任研究者：
      
      Patrick Danaher, MD
- Virginia
  - Portsmouth、Virginia、アメリカ、23708
    - 募集
    - Naval Medical Center, Portsmouth, VA
    - コンタクト：
      
      Rezalina Tant
      
      電話番号：757-953-5603
      
      メール：rezalina.g.tant.ctr@mail.mil
    - コンタクト：
      
      Realisha Smith
      
      電話番号：757-953-6971
      
      メール：realisha.b.smith.ctr@mail.mil
    - 副調査官：
      
      Tahaniyat Lalani, MD
- Washington
  - Tacoma、Washington、アメリカ、98431
    - 募集
    - Madigan Army Medical Center (MAMC)
    - コンタクト：
      
      Susan Chambers, RN
      
      電話番号：253-968-1643
      
      メール：susan.e.chambers4.ctr@mail.mil
    - コンタクト：
      
      Debra Angell, CCRP
      
      電話番号：253-968-4596
      
      メール：debra.a.angell.ctr@mail.mil
    - 副調査官：
      
      Mary Fairchok, MD
    - 主任研究者：
      
      Christina Schofield, MD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

17年～55年 (子、大人)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

サンプリング方法

確率サンプル

調査対象母集団

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.

説明

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 DoD facilities (DEERS eligible).
Have an acute influenza-like illness (ILI) or severe acute respiratory infection (SARI) for </= 7 days

Exclusion Criteria:

Proven Group A Streptococcal infection

Note that proven Group A Streptococcal infection will not be exclusionary IF it is proven to be a co-infection with another respiratory pathogen.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

グループ/コホートの数

コホートと介入

グループ/コホート
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.

グループ/コホート

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.

この研究は何を測定していますか？

主要な結果の測定

結果測定	時間枠
Develop a consortium of Department of Defense research sites capable of collecting detailed prospective clinical data, and biologic samples from active duty members and their families with ILI. 時間枠：7 years	7 years

二次結果の測定

結果測定	時間枠
Develop and validate an influenza severity scale 時間枠：6 months	6 months
Study the relationship between health and fitness of young adults to outcomes of influenza and other respiratory viruses 時間枠：1 year	1 year
Examine the relationship of cell-mediated and humoral immune response to the severity of influenza and other respiratory viruses. 時間枠：1 year	1 year
Describe patterns of viral shedding in different influenza types and subtypes. 時間枠：1 year	1 year
Correlate clinical severity and cytokine/humoral response with underlying host genotype. 時間枠：1 year	1 year

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Uniformed Services University of the Health Sciences

協力者

National Institute of Allergy and Infectious Diseases (NIAID)

捜査官

主任研究者：Timothy H Burgess, MD, MPH、Uniformed Services University of the Health Sciences/Infectious Disease Clinical Research Program

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2009年11月1日

一次修了 (予想される)

2017年12月1日

研究の完了 (予想される)

2018年12月1日

試験登録日

最初に提出

2009年11月10日

QC基準を満たした最初の提出物

2009年11月25日

最初の投稿 (見積もり)

2009年11月26日

学習記録の更新

投稿された最後の更新 (見積もり)

2016年12月23日

QC基準を満たした最後の更新が送信されました

2016年12月22日

最終確認日

2016年12月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

IDCRP-045

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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.

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。