Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT00284869
Status:
COMPLETED
Last Update Posted:
2006-09-13
First Post:
2006-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ethnic Differences in the Inflammatory Response in Systemic Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019446', 'term': 'Endotoxemia'}], 'ancestors': [{'id': 'D016470', 'term': 'Bacteremia'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014115', 'term': 'Toxemia'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'ECT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2006-04'}, 'lastUpdateSubmitDate': '2006-09-11', 'studyFirstSubmitDate': '2006-01-31', 'studyFirstSubmitQcDate': '2006-01-31', 'lastUpdatePostDateStruct': {'date': '2006-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'neutrophil counts'}, {'measure': 'IL-8'}, {'measure': 'G-CSF'}], 'secondaryOutcomes': [{'measure': 'various inflammation and coagulation parameters'}, {'measure': 'Platelets'}, {'measure': 'Adverse events'}]}, 'conditionsModule': {'keywords': ['LPS', 'ethnicity', 'neutrophils', 'TNF'], 'conditions': ['Endotoxemia']}, 'referencesModule': {'references': [{'pmid': '16413239', 'type': 'BACKGROUND', 'citation': 'Leitner JM, Firbas C, Mayr FB, Reiter RA, Steinlechner B, Jilma B. Recombinant human antithrombin inhibits thrombin formation and interleukin 6 release in human endotoxemia. Clin Pharmacol Ther. 2006 Jan;79(1):23-34. doi: 10.1016/j.clpt.2005.10.003.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate putative ethnic differences in the proinflammatory response in human endotoxemia.', 'detailedDescription': 'Recent data show that there are significant disparities among genders and races in the incidence of sepsis. While men are consistently more likely to have sepsis than women, the apparent racial disparities are even more striking, approaching a doubling of the risk for sepsis among Afro-Americans. Most prominent is the risk among black men, the group in which sepsis occurs at the youngest age and results in the most deaths. Potential mechanisms for heterogeneous susceptibility to sepsis include genetic differences, which have been explored according to sex but not according to race, and other social and clinical factors.\n\nThe goal of this study is to explore whether proinflammatory and procoagulant responses in a well standardised inflammation model are comparable in healthy Caucasian and African volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent obtained before any trial-related activities. (Trial activities are any procedure that would not have been performed during normal management of the subject).\n* Men aged \\>18 and \\<40 years\n* Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant\n* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant\n\nExclusion Criteria:\n\n* Treatment with an investigational drug within three weeks prior to this trial\n* Participation in an LPS trial within the last 6 weeks\n* Hereditary deficiency of protein C or S, or a mutation of FV (Leiden), or any other known abnormality affecting coagulation, fibrinolysis or platelet function\n* History of cardiovascular disease\n* Liver or kidney dysfunction\n* Regular use of medication or alcohol abuse\n* Use of any medication within three weeks prior to the first trial day\n* Symptoms of a clinically relevant illness in the 3 weeks before the first trial day\n* Excessive sporting activities\n* Weight over 95 kg'}, 'identificationModule': {'nctId': 'NCT00284869', 'briefTitle': 'Ethnic Differences in the Inflammatory Response in Systemic Inflammation', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Ethnic Differences in the Inflammatory Response in Systemic Inflammation', 'orgStudyIdInfo': {'id': 'EK255/2005'}}, 'armsInterventionsModule': {'interventions': [{'name': 'LPS', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'state': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna, Dept. of Clinical Pharmacology', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Christa Firbas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna, Department of Clinical Pharmacology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}}}}