NCT01215604

Brief Summary

The investigators propose that the translation initiation factors eIF4E and eIF4GI may be involved in resolution of acute inflammation (regardless of age). Furthermore, the investigators suggest that differences in translation initiation factors state of activation may contribute to inflammation. Finally, the investigators hypothesize that differences in translation initiation factors state of activation may underlie the immune compromised state of the very elderly affording additional explanation for the heightened morbidity from infection in this group. In the current study the investigators aim to test these hypotheses by measuring the levels of eIF4E and eIF4G, their regulators, and targets in elderly (65-84yrs) and very elderly (85yrs\<) patients hospitalized at Meir hospital for acute infection and after their recovery (detailed in study design).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

March 19, 2012

Status Verified

March 1, 2012

Enrollment Period

1 year

First QC Date

October 5, 2010

Last Update Submit

March 16, 2012

Conditions

Keywords

elderly patientsacute infectiontranslation initiation factorseIF4EeIF4G

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

patient aged \>65 years admitted to internal medicine or geriatric departments due to acute infection with fever and leukocytosis.

You may qualify if:

  • elderly patients (65\<)
  • hospitalized for acute infection (fever 38c\<, leukocytosis)

You may not qualify if:

  • patients with dementia who can not sign informed consent of institutional Helsinki committee
  • patient with active cancer with active chemotherapy treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples of elderly patients diagnosed with acute infection will be collected at admittance to Meir hospital and on recovery (24-48 hours without fever and leukocytosis)

MeSH Terms

Conditions

Infections

Study Officials

  • Rachel Heffez Ayzenfeld, MD

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2010

First Posted

October 6, 2010

Study Start

October 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2012

Last Updated

March 19, 2012

Record last verified: 2012-03

Locations