Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-30 @ 4:49 AM
Study NCT ID:
NCT01133834
Status:
COMPLETED
Last Update Posted:
2011-06-15
First Post:
2010-05-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Cytokines and the Severity of Meningococcal Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008589', 'term': 'Meningococcal Infections'}], 'ancestors': [{'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'blood sample cerebral spinal fluid'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2003-02', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-14', 'studyFirstSubmitDate': '2010-05-27', 'studyFirstSubmitQcDate': '2010-05-28', 'lastUpdatePostDateStruct': {'date': '2011-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'shock', 'timeFrame': '24 hours', 'description': 'low blood pressure'}], 'secondaryOutcomes': [{'measure': 'acute kidney injury', 'timeFrame': '3 days', 'description': 'elevation of serum creatinine levels'}, {'measure': 'disseminated intravascular coagulation', 'timeFrame': '24 hours', 'description': 'plaquetopenia, coagulopathy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['meningococcal disease', 'cytokines'], 'conditions': ['Meningococcemia']}, 'descriptionModule': {'briefSummary': 'Objectives:\n\nMeningococcal disease (MD) is a complex catastrophic phenomenon that can converge rapidly to irreversible septic shock, myocardial dysfunction, and profound coagulopathy. During meningococcal sepsis and meningitis, a myriad of cells release cytokines within the intravascular environment and subarachnoid space. Cytokines are key molecular messengers that play key roles in orchestrating and mediating the metabolic, endocrine and coagulation responses to meningococcal infection. The aim of the present study is to determine the profile of different cytokines in serum and cerebrospinal fluid during MD, as well as relate the level of these cytokines to severity of MD.\n\nDesign:\n\nProspective, nonrandomized study.\n\nSetting:\n\nTertiary referral intensive care unit.\n\nPatients:\n\nChildren and adults admitted with a clinical diagnosis of MD. Interventions: Blood and cerebrospinal fluid will sample from children and adults with MD.', 'detailedDescription': 'Meningococcal disease (MD) is a complex catastrophic phenomenon that can converge rapidly to irreversible septic shock, myocardial dysfunction, and profound coagulopathy. During meningococcal sepsis and meningitis, a myriad of cells release cytokines within the intravascular environment and subarachnoid space. Cytokines are key molecular messengers that play key roles in orchestrating and mediating the metabolic, endocrine and coagulation responses to meningococcal infection. The aim of the present study is to determine the profile of different cytokines in serum and cerebrospinal fluid during MD:\n\nIL -4; IL-6; IL-10 and interferon alfa, as well as relate the level of these cytokines to severity of MD, evaluated by occurrence of shock, acute renal failure, disseminated intravascular coagulation and survival.\n\nDesign: Prospective, nonrandomized study. Setting: Tertiary referral intensive care unit. Patients: Children and adults admitted with a clinical diagnosis of MD. Interventions: Blood and cerebrospinal fluid will sample from children and adults with MD.\n\nMeasurements and Main Results: in process Conclusions: in process'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '6 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted at the Intensive Care Unit of the Instituto de Infectologia Emílio Ribas', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnostic of meningococcal disease\n\nExclusion Criteria:\n\n* no meningococcal disease'}, 'identificationModule': {'nctId': 'NCT01133834', 'briefTitle': 'Correlation Between Cytokines and the Severity of Meningococcal Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Clinical and Laboratorial Factors Associated With the Severity of Meningococcal Disease', 'orgStudyIdInfo': {'id': 'meningococcemia'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with meningococcemia', 'description': 'Patients with meningococcemia admitted at the Intensive Care Unit'}]}, 'contactsLocationsModule': {'locations': [{'zip': '01246-903', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'University of São Paulo General Hospital - LIM-12 and LIM-56', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Antonio C Seguro, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital das Clínicas USP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto de Infectologia Emílio Ribas', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Antonio Carlos Seguro', 'oldOrganization': 'University of São Paulo School of Medicine'}}}}