Elderly PatientNCT01215604
Involvement of Translation Initiation Factors in the Immune Response in the Elderly
An observational study of Elderly Patient and Infection, run by Meir Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Elderly Patient, Infection
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2010to Oct 2012
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: patient aged >65 years admitted to internal medicine or geriatric departments due to acute infection with fever and leukocytosis.
Who may be able to join
- elderly patients (65<)
- hospitalized for acute infection (fever 38c<, leukocytosis)
Who cannot join
- patients with dementia who can not sign informed consent of institutional Helsinki committee
- patient with active cancer with active chemotherapy treatment
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba
Racheli Heffez, MD, 972-9-7472181, rachelhe2@clalit.org.il
rachel Heffez Ayzenfeld, MD
About this study
Official title: Characterization of the Involvement of Translation Initiation Factors in the Immune Response to Acute Infection in the Elderly and Very Elderly
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).
- Conditions
- Elderly Patient, Infection
- Keywords
- elderly patients, acute infection, translation initiation factors, eIF4E, eIF4G
- Medical subject headings
- Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2011
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly PatientStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 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, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215604
- Sponsor's protocol ID
- MMC10156-2010CTIL
- Status last verified
- Mar 2012
- First submitted
- 5 Oct 2010
- Last updated
- 19 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Involvement of Translation Initiation Factors in the Immune Response to Acute Infection in the Elderly and Very Elderly
- ClinicalTrials.gov ID
- NCT01215604
- Acronym / sponsor ID
- MMC10156-2010CTIL
- Conditions
- Elderly Patient, Infection
- Keywords
- elderly patients, acute infection, translation initiation factors, eIF4E, eIF4G
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2012 (estimated)
- First posted
- 6 Oct 2010 (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.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- patient aged >65 years admitted to internal medicine or geriatric departments due to acute infection with fever and leukocytosis.
Key inclusion criteria (2 listed)
- elderly patients (65<)
- hospitalized for acute infection (fever 38c<, leukocytosis)
Key exclusion criteria (2 listed)
- patients with dementia who can not sign informed consent of institutional Helsinki committee
- patient with active cancer with active chemotherapy treatment
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2012.
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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
Meir Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elderly Patient and Infection, run by Meir Medical Center at 1 site in Israel.
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 2 inclusion and 2 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 19 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
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 19 Mar 2012.