Involvement of the Translation Initiation Factors in Reso... | NCT02519361

Studies
Involvement of the Translation Initiation Factors in Resolution of Inflammation in the Elderly Population

NCT02519361

Sponsor

Meir Medical Center

Status

Unknown status

Last Update Posted

Aug 10, 2015Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Infection in the Elderly

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2015

Primary Completion Date

Jan 2016Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

Aug 2, 2015

First Submission Date that Met QC Criteria

Aug 5, 2015

First Posted Date

Aug 10, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2015

Last Update Posted Date

Aug 10, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Aging cause specific changes in the immune system. Processes like "immunoessence" and "inflammaging" offend the functioning of the immune cells and expose the elderly patient to infections that can lead to morbidity and death.

Protein translation regulation offers a strategic advantage to the immune cells, because it enables rapid activation or termination of synthesis of specific proteins, required for inflammation or its resolution. Translation initiation depends on recruitment of eukaryotic initiation factor "eIF4F" complex.

The aim of the current study is to investigate the involvement of the translation initiation factors (eIF4E and eIF4G) in the process of recovery from acute infection in elderly patient admitted to the internal department with an acute infection.

Detailed Description

Blood samples of elderly patients diagnosed with acute infection (fever and leukocytosis) will be collected twice - at admittance to Meir hospital and after recovery (24-48 hours without fever and leukocytosis). evidence of infection (chest x ray, urine and blood samples) will be collected. participants will be divided to two age groups: 65-80 yrs and very old patient >85 yrs, and will be compared to younger patients aged 50-65.
Peripheral blood samples will be separated to subpopulations of lymphocytes, monocytes and polymorphonuclears, and protein will be extracted.
protein lysates will be separated by SDS-PAGE electrophoresis and immunoblotted for phosphorylated and total eIF4E and eIF4G; their regulators: Mnk 1/2, 4EBP1, mTOR and targets: cyclin D1, c-Myc, survivin, BCL2, VEGFA, etc.
Paired samples (within each age group) will be analyzed and correlated with clinical response of the patients. The source of the infection will also be considered.
Comparison between age groups at admittance and upon recovery will be made (Unpaired).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Translation initiation factors expression by immunoblotting, in leukocytes sub population	Assessment of eIF4E and eIF4G expression by immunoblotting, in leukocytes sub populations under inflamed conditions and upon resolution of acute inflammation, in three groups of age	1 week

Secondary Outcomes

Measure	Description	Time Frame
Translation initiation factors regulators expression by immunoblotting in leukocytes sub population	Assessment of eIF4E and eIF4G regulators expression by immunoblotting, in leukocytes sub populations under inflamed conditions and upon resolution of acute inflammation in three age groups	1 week
Translation initiation factors targets expression by immunoblotting in leukocytes sub population

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient aged 50 y and more with:
fever >38c that started in the 48 hours prior to admission
leukocytosis >10.0 K/microLiter
suspected source of infection by symptoms, lab results or imaging
treatment with antibiotics started in the last 24 hours or is about to be started

Exclusion Criteria:

patients who cannot sign the informed concent ( dementia)
patients with active malignancy
patients who are under chemotherapy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients admitted to internal department due to acute infection

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
rachel heffez ayzenfeld, MD	Contact	09 7472185		rachelhe2@clalit.org.il

Overall Officials

Name	Affiliation	Role
Rachel Heffez Ayzenfeld, MD	r.h.ayzenfeld	Principal Investigator

Locations

Not provided