- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00421837
Pilot Study of Genotypic Analysis
15 août 2013 mis à jour par: National Institute of Allergy and Infectious Diseases (NIAID)
Pilot Study of the Genotypic Analysis of Patients Infected With Influenza Virus Compared With Uninfected Spouse/Close Contact Controls
Influenza (the flu) is a leading cause of respiratory (breathing) illness that leads to sickness and death during the winter months.
A better understanding of why certain people get the flu or get sicker with the flu than other people is important for developing improved vaccines and treatments.
This study will look at the genetic makeup (determines each person's specific characteristics and traits) of 50 patients, older than 50, who were hospitalized with flu at Vanderbilt University during the 2006-2007 flu season.
Their genetic makeup will be compared with the genetic makeup of 50 people who are not related but were in close daily contact with the flu patient and were not infected with flu virus.
The study staff will collect a blood sample (contains genetic material) from each participant (flu patients and their contacts) for comparison.
Flu patients will have completed a health survey as part of the previous study, and their contacts will complete a shorter version of this survey.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
Influenza is a leading vaccine preventable cause of respiratory illness that leads to substantial morbidity and mortality during the winter months.
It is defined by a rapid-onset systemic illness, with patients presenting with fever, chills, cough, myalgias, headache and sore throat.
Given the huge health burden caused by influenza and the ever present threat of a future pandemic, a better understanding of population genetic variation and its association with severe outcomes from influenza infection is critical for developing improved vaccines and treatments for the entire population of at risk persons.
This study is a single-center, specimen collection pilot protocol designed to compare the genotype of patients, aged greater than 50 years, who are hospitalized with respiratory symptoms or fever at Vanderbilt University with culture or PCR confirmed influenza virus infection with individuals who are not related but are in close daily contact with the subject and are not infected with influenza virus during the 2006 - 2007 influenza season.
This study is linked to DMID protocol 06-0051.
All subjects will be recruited from those subjects who have been enrolled in Division of Microbiology and Infectious Diseases (DMID) parent study 06-0051, a Vaccine and Treatment Evaluation Units (VTEU)-funded respiratory disease surveillance study conducted during the 2006 - 2007 influenza season.
If the subject has completed the surveillance parent study, (DMID study 06-0051), then he/she must have agreed to be contacted for future studies on the surveillance consent prior to enrollment into this sub-study.
Controls for this study will be recruited via the index cases.
This study will enroll 100 subjects total, 50 study subjects and 50 control subjects.
The 50 study subjects will include individuals hospitalized with respiratory symptoms or fever and infected with influenza virus.
The 50 control subjects will be uninfected, non-related individuals living in the same household or in close daily contact with the subject.
The study staff will obtain 15 ml venous blood sample from each subject for genotyping studies.
Subjects will have completed a health assessment as part of the parent trial and controls will be asked a shorter version of this survey which includes items such as: demographics, chronic disease history, history of immunosuppressive drugs or conditions, vaccination history, smoking history, and living conditions.
The primary objectives of the study are to conduct whole genome array analysis on individuals with confirmed influenza virus infection and to compare their genotype with individuals who were likely exposed to influenza due to close daily contact, but are not genetically related.
Type d'étude
Observationnel
Inscription (Réel)
6
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
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Tennessee
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Nashville, Tennessee, États-Unis, 37232-2573
- Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center
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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
50 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Subjects > 55 yo hospitalized with Influenza vs healthy household members and close contacts
La description
Inclusion Criteria:
- Male or female, aged greater than or equal to 50 years
- For SUBJECTS: Enrolled in a Vaccine Treatment and Evaluation Unit (VTEU)-funded surveillance study conducted during the 2006 - 2007 influenza season [Division of Microbiology and Infectious Diseases (DMID) study 06-0051]
- Residents of surveillance areas
- For SUBJECTS: Persons who have been hospitalized with respiratory symptoms or fever and polymerase chain reaction (PCR) or culture confirmed influenza virus OR
- For CONTROLS: Living with or in frequent contact with SUBJECT
- For CONTROLS: Genetically unrelated to the SUBJECT
- Willing and able to provide signature documentation of informed consent or parental permission
Exclusion Criteria:
- For SUBJECTS: Not enrolled in a Vanderbilt led respiratory disease surveillance study [Division of Microbiology and Infectious Diseases (DMID) study 06-0051]
- For SUBJECTS: Receipt of blood products in the past 6 months
- Anything in the opinion of the Investigator that would prevent the subject from successfully participating in this study
- For CONTROLS: Influenza infection during the 2006-2007 flu season
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 |
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controls
household and other close contacts
|
cases
elderly (>55) subjects hospitalized with Influenza
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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phenotypic analysis
Délai: at analysis
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at analysis
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
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 mai 2007
Achèvement primaire (Réel)
1 décembre 2008
Achèvement de l'étude (Réel)
1 décembre 2008
Dates d'inscription aux études
Première soumission
11 janvier 2007
Première soumission répondant aux critères de contrôle qualité
11 janvier 2007
Première publication (Estimation)
12 janvier 2007
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
16 août 2013
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 août 2013
Dernière vérification
1 avril 2011
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 06-0092
- N01AI80007C
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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