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Acute Respiratory Infection Consortium (ARIC)

22. Dezember 2016 aktualisiert von: 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.

Studienübersicht

Status

Unbekannt

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

2000

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • California
      • San Diego, California, Vereinigte Staaten, 92134
    • Georgia
      • Columbus, Georgia, Vereinigte Staaten, 31905
        • Rekrutierung
        • Martin Army Community Hospital, Fort Benning, GA
        • Kontakt:
          • Natasha Law, MA
          • Telefonnummer: 706-544-6583
        • Kontakt:
          • Arile Hadley
          • Telefonnummer: 7065443496
        • Hauptermittler:
          • CPT Naimyah Yehudah, PA-C
    • Maryland
      • Bethesda, Maryland, Vereinigte Staaten, 20814
    • Texas
      • San Antonio, Texas, Vereinigte Staaten, 78234
    • Virginia
      • Portsmouth, Virginia, Vereinigte Staaten, 23708
    • Washington
      • Tacoma, Washington, Vereinigte Staaten, 98431
        • Rekrutierung
        • Madigan Army Medical Center (MAMC)
        • Kontakt:
        • Kontakt:
        • Unterermittler:
          • Mary Fairchok, MD
        • Hauptermittler:
          • Christina Schofield, MD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

17 Jahre bis 55 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
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.
Zeitfenster: 7 years
7 years

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Uniformed Services University of the Health Sciences

Mitarbeiter

National Institute of Allergy and Infectious Diseases (NIAID)

Ermittler

  • Hauptermittler: Timothy H Burgess, MD, MPH, Uniformed Services University of the Health Sciences/Infectious Disease Clinical Research Program

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. November 2009

Primärer Abschluss (Voraussichtlich)

1. Dezember 2017

Studienabschluss (Voraussichtlich)

1. Dezember 2018

Studienanmeldedaten

Zuerst eingereicht

10. November 2009

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. November 2009

Zuerst gepostet (Schätzen)

26. November 2009

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

23. Dezember 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. Dezember 2016

Zuletzt verifiziert

1. Dezember 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IDCRP-045

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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.

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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