Infection in the ElderlyNCT02519361
Involvement of the Translation Initiation Factors in Resolution of Inflammation in the Elderly Population
An observational study of Infection in the Elderly, run by Meir Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Infection in the Elderly
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients admitted to internal department due to acute infection
Who may be able to join
- 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
Who cannot join
- patients who cannot sign the informed concent ( dementia)
- patients with active malignancy
- patients who are under chemotherapy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Involvement of the Translation Initiation Factors eIF4E and eIF4G in Resolution of Inflammation in the Elderly Population
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.
Read the 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).
- Conditions
- Infection in the Elderly
- Keywords
- elderly, immune response, acute infection
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week
Secondary outcomes (2)
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
Measured: 1 week
Translation initiation factors targets expression by immunoblotting in leukocytes sub population
Assessment of eIF4E and eIF4G targets expression by immunoblotting in leukocytes sub populations under inflamed conditions and upon resolution of acute inflammation, in three age groups
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection in the ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Heffez Ayzenfeld, MD, Principal investigator, r.h.ayzenfeld
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519361
- Sponsor's protocol ID
- 0148-15-MMC
- Status last verified
- Aug 2015
- First submitted
- 2 Aug 2015
- Last updated
- 10 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Involvement of the Translation Initiation Factors eIF4E and eIF4G in Resolution of Inflammation in the Elderly Population
- ClinicalTrials.gov ID
- NCT02519361
- Acronym / sponsor ID
- 0148-15-MMC
- Conditions
- Infection in the Elderly
- Keywords
- elderly, immune response, acute infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 10 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted to internal department due to acute infection
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- patients who cannot sign the informed concent ( dementia)
- patients with active malignancy
- patients who are under chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Translation initiation factors expression by immunoblotting, in leukocytes sub population
Time frame: 1 week
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
2 secondary outcomes
Translation initiation factors regulators expression by immunoblotting in leukocytes sub population
Time frame: 1 week
Translation initiation factors targets expression by immunoblotting in leukocytes sub population
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Heffez Ayzenfeld, MD principal investigator
r.h.ayzenfeld
Questions about this trial
What is this clinical trial studying?
An observational study of Infection in the Elderly, run by Meir Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact rachel heffez ayzenfeld, MD (09 7472185, rachelhe2@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Translation initiation factors expression by immunoblotting, in leukocytes sub population (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2015.