Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-31 @ 4:48 AM
Study NCT ID:
NCT01215604
Status:
UNKNOWN
Last Update Posted:
2012-03-19
First Post:
2010-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Involvement of Translation Initiation Factors in the Immune Response in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '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)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-16', 'studyFirstSubmitDate': '2010-10-05', 'studyFirstSubmitQcDate': '2010-10-05', 'lastUpdatePostDateStruct': {'date': '2012-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['elderly patients', 'acute infection', 'translation initiation factors', 'eIF4E', 'eIF4G'], 'conditions': ['Elderly Patient', 'Infection']}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patient aged \\>65 years admitted to internal medicine or geriatric departments due to acute infection with fever and leukocytosis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elderly patients (65\\<)\n* hospitalized for acute infection (fever 38c\\<, leukocytosis)\n\nExclusion Criteria:\n\n* patients with dementia who can not sign informed consent of institutional Helsinki committee\n* patient with active cancer with active chemotherapy treatment'}, 'identificationModule': {'nctId': 'NCT01215604', 'briefTitle': 'Involvement of Translation Initiation Factors in the Immune Response in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'Characterization of the Involvement of Translation Initiation Factors in the Immune Response to Acute Infection in the Elderly and Very Elderly', 'orgStudyIdInfo': {'id': 'MMC10156-2010CTIL'}}, 'contactsLocationsModule': {'locations': [{'city': 'Kfar Saba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Racheli Heffez, MD', 'role': 'CONTACT', 'email': 'rachelhe2@clalit.org.il', 'phone': '972-9-7472181'}, {'name': 'rachel Heffez Ayzenfeld, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}], 'overallOfficials': [{'name': 'Rachel Heffez Ayzenfeld, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meir Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}