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Acute Respiratory Infection Consortium (ARIC)

22 décembre 2016 mis à jour par: 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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Anticipé)

2000

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • California
      • San Diego, California, États-Unis, 92134
        • Recrutement
        • Naval Medical Center, San Diego, CA
        • Contact:
        • Contact:
        • Sous-enquêteur:
          • Alona Diem
    • Georgia
      • Columbus, Georgia, États-Unis, 31905
        • Recrutement
        • Martin Army Community Hospital, Fort Benning, GA
        • Contact:
          • Natasha Law, MA
          • Numéro de téléphone: 706-544-6583
        • Contact:
          • Arile Hadley
          • Numéro de téléphone: 7065443496
        • Chercheur principal:
          • CPT Naimyah Yehudah, PA-C
    • Maryland
      • Bethesda, Maryland, États-Unis, 20814
    • Texas
      • San Antonio, Texas, États-Unis, 78234
        • Recrutement
        • San Antonio Military Medical Center/Wilford Hall
        • Contact:
        • Contact:
        • Chercheur principal:
          • Patrick Danaher, MD
    • Virginia
      • Portsmouth, Virginia, États-Unis, 23708
    • Washington
      • Tacoma, Washington, États-Unis, 98431
        • Recrutement
        • Madigan Army Medical Center (MAMC)
        • Contact:
        • Contact:
        • Sous-enquêteur:
          • Mary Fairchok, MD
        • Chercheur principal:
          • Christina Schofield, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

17 ans à 55 ans (Enfant, Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

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.

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
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.
Délai: 7 years
7 years

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Uniformed Services University of the Health Sciences

Collaborateurs

National Institute of Allergy and Infectious Diseases (NIAID)

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 novembre 2009

Achèvement primaire (Anticipé)

1 décembre 2017

Achèvement de l'étude (Anticipé)

1 décembre 2018

Dates d'inscription aux études

Première soumission

10 novembre 2009

Première soumission répondant aux critères de contrôle qualité

25 novembre 2009

Première publication (Estimation)

26 novembre 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

23 décembre 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 décembre 2016

Dernière vérification

1 décembre 2016

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IDCRP-045

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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.

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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