Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT00946218
Status:
COMPLETED
Last Update Posted:
2011-10-05
First Post:
2009-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnosis and Characterization of Dengue Fever in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003715', 'term': 'Dengue'}], 'ancestors': [{'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018177', 'term': 'Flavivirus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006482', 'term': 'Hemorrhagic Fevers, Viral'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 258}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-03', 'studyFirstSubmitDate': '2009-07-22', 'studyFirstSubmitQcDate': '2009-07-23', 'lastUpdatePostDateStruct': {'date': '2011-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare the sensitivity of dengue NS1 (influenze protein) Ag Enzyme-linked Immunosorbent Assay and dengue NS1 Ag STRIP and WHO clinical diagnostic criteria when applied to children in El Salvador.', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'To identify differences in host leukocyte gene expression in children with DF, DHF, and DSS using high throughput gene expression arrays.', 'timeFrame': '1 Year'}, {'measure': 'To develop a clinical risk algorithm for predicting severe dengue using NS1 Ag testing techniques and clinical data.', 'timeFrame': '1 Year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dengue Fever']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.stjude.org', 'label': "St. Jude Children's Research Hospital"}]}, 'descriptionModule': {'briefSummary': 'Dengue virus is an arbovirus transmitted by mosquitoes which causes significant morbidity and mortality among children in tropical regions, especially in resource limited countries. The objective of this protocol is to compare the sensitivity and specificity of clinical gestalt and two rapid antigen tests for dengue virus and to compare the gene expression of leukocytes in distinct dengue fever disease phenotypes module-based RNA microarray technology.', 'detailedDescription': 'This is a biology protocol with no treatment regimen associated. Blood collection will be drawn from subjects in El Salvador to be tested in an effort to improve detection and test sensitivity and specificity of a dengue NS1 Ag ELISA, dengue NS1 Ag STRIP, and clinical suspicion for the detection of dengue virus infection in children in San Salvador, El Salvador compared to the gold standard, PCR. This protocol will also seek to identify and compare gene transcription patterns characteristics of each dengue virus disease phenotype in children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Children subject presenting to Benjamin Bloom Children's Hospital in San Salvador, El Salvador.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria Part A:\n\n* Age: Greater than or equal to 6 months and less than 13 years\n* One of the following; History of fever OR a history of spontaneous or provoked bleeding\n\nInclusion Criteria Part B:\n\n* Gender: Female\n* Age: greater than or equal to 36 months\n* Tanner stage less than 2\n* One of the following criteria: Classical Dengue Fever, Dengue Hemorrhagic Fever or Dengue Shock Syndrome\n\nExclusion Criteria for both parts:\n\n* Obvious alternative explanation for the actual illness\n* Cellulitis/Abscess\n* Osteomyelitis\n* Varicella\n* Urinary Tract Infection\n* Known immunocompromising condition'}, 'identificationModule': {'nctId': 'NCT00946218', 'briefTitle': 'Diagnosis and Characterization of Dengue Fever in Children', 'organization': {'class': 'OTHER', 'fullName': "St. Jude Children's Research Hospital"}, 'officialTitle': 'Diagnosis and Characterization of Dengue Fever in Children', 'orgStudyIdInfo': {'id': 'DENGEN'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Part A', 'description': 'Children with presumptive dengue infection enrolled for empiric cost modeling with retrospective clinical estimation and comparison of test performance to the standard of care.'}, {'label': 'Part B', 'description': 'Children with definitive dengue infection enrolled for gene expression analysis.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'city': 'San Salvador', 'state': 'El Salvador', 'country': 'El Salvador', 'facility': 'Hospital Nacional de Ninos Benjamin Bloom', 'geoPoint': {'lat': 13.68935, 'lon': -89.18718}}], 'overallOfficials': [{'name': 'Elisabeth Adderson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Jude Children's Research Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Jude Children's Research Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}