NCT00823589

Brief Summary

Ageing is associated with vulnerability against infections leading to increased morbidity with risk of death. Innate and adaptive immunities are altered with ageing responsible of deficits in immune response against pathogens and after vaccination, and favouring the elderly vulnerability against a new pathogen with increased bacterial, viral, and fungal infections. If immunity has been widely studied in immunosenescence, there are few prospective, comparative studies with elderly ill patients. Moreover among these studies, pathologies are not well defined. The main objective of our project is to compare the immune state of elderly hospitalised subjects in an acute geriatric unit to the immune state of elderly healthy subjects selected with strict criteria, in order to precise the impact of polypathology and of various pathologies on immunity state.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

January 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 25, 2014

Status Verified

February 1, 2014

Enrollment Period

3.1 years

First QC Date

January 14, 2009

Last Update Submit

February 24, 2014

Conditions

Keywords

ELDERLY POPULATION

Outcome Measures

Primary Outcomes (1)

  • compare the immune state of elderly hospitalised subjects in an acute geriatric unit to the immune state of elderly healthy subjects

    2 years

Study Arms (2)

pathological group

EXPERIMENTAL

pathological group

Other: Blood test and clinical test

healthy aged

EXPERIMENTAL

healthy aged

Other: Blood test and clinical test

Interventions

Blood test and clinical test

healthy agedpathological group

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Subject of 75 or more years old, female or male
  • Subject admitted in the service of short stay gériatrique of the hospital Holy Marguerite, whatever is the motive for admittance
  • Subject not being under supervision(guardianship), nor guardianship
  • Subject benefiting from a benefit system
  • Subject having given its assent of participation or for which the reliable person gave her assent in the case of vulnerable person

You may not qualify if:

  • Subject of less than 75 years old
  • Subject refusing to participate in the study or for whom(which) the reliable person refuses the participation of the subject

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HOPITAL DE SAINTE MARGUERITE Service de Gériatrie Sud

Marseille, Paca, France

Location

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • ELODIE CRETEL

    Assistance Publique Hopitaux De Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2009

First Posted

January 15, 2009

Study Start

January 1, 2009

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

February 25, 2014

Record last verified: 2014-02

Locations