Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-31 @ 8:14 PM
Study NCT ID:
NCT01421732
Status:
COMPLETED
Last Update Posted:
2016-09-30
First Post:
2011-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laboratory Diagnosis and Prognosis of Severe Dengue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003715', 'term': 'Dengue'}, {'id': 'D004194', 'term': 'Disease'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-29', 'studyFirstSubmitDate': '2011-08-22', 'studyFirstSubmitQcDate': '2011-08-22', 'lastUpdatePostDateStruct': {'date': '2016-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue.', 'timeFrame': 'Within the first 72 hours of fever onset', 'description': 'Percentage of detection assays which correctly predict laboratory-confirmed severe dengue.'}, {'measure': 'Specificity of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue.', 'timeFrame': 'Within the first 72 hours of fever onset', 'description': 'Percentage of detection assays which correctly predict different dengue serotypes.'}, {'measure': 'Positive predictive values of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue.', 'timeFrame': 'Within the first 72 hours of fever onset', 'description': 'Percentage of detection assays which correctly predict dengue infection.'}, {'measure': 'Negative predictive values of the NS1 detection assays for diagnosis of laboratory-confirmed severe dengue.', 'timeFrame': 'Within the first 72 hours of fever onset', 'description': 'Percentage of detection assays which correctly predict no dengue infection.'}], 'secondaryOutcomes': [{'measure': 'Positive predictive values of the NS1 detection assays for children requiring hospitalization or parenteral fluid therapy.', 'timeFrame': 'Estimated within 6 days of presentation', 'description': 'Percentage of detection assays which correctly predict requirement of hospitalization and/or parenteral fluid therapy (dehydration, vomiting or signs of capillary permeability).'}, {'measure': 'Negative predictive values of the NS1 detection assays for children requiring hospitalization or parenteral fluid therapy.', 'timeFrame': 'Estimated within 6 days of presentation', 'description': 'Percentage of detection assays which correctly predict no requirement of hospitalization and/or parenteral fluid therapy (dehydration, vomiting or signs of capillary permeability).'}, {'measure': 'Sensitivity of the NS1 detection assays to predict the requirement of hospitalization or parenteral fluid therapy.', 'timeFrame': 'Estimated within 6 days of presentation', 'description': 'Percentage of detection assays which correctly predict the requirement of hospitalization and/or parenteral fluid therapy (dehydration, vomiting or signs of capillary permeability).'}, {'measure': 'Specificity of the NS1 detection assays to predict the dengue serotype which corresponds to the requirement of hospitalization or parenteral fluid therapy.', 'timeFrame': 'Estimated within 6 days of presentation', 'description': "Percentage of detection assays which correctly predict the dengue serotype and it's correlation to a requirement of hospitalization and/or parenteral fluid therapy (dehydration, vomiting or signs of capillary permeability)."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dengue fever', 'severe dengue fever', 'NS1 detection assay', 'Prognosis', 'Diagnosis'], 'conditions': ['Dengue Fever']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.oucru.org', 'label': 'Oxford University Clinical Research Unit'}, {'url': 'http://www.oucru.org/index.php?option=com_content&view=article&id=336&Itemid=111&lang=en', 'label': 'Study details and Informed Consent Form'}]}, 'descriptionModule': {'briefSummary': 'A study of dengue in children presenting to outpatient departments of 5 large hospitals in Ho Chi Minh City and Tien Giang province, Viet Nam.\n\nDifferent blood tests are compared at the early stages of dengue fever onset in their ability to accurately and specifically detect children whose dengue will progress to severe disease.', 'detailedDescription': 'In a prospective study in the outpatients department of three large hospitals in Ho Chi Minh City, Viet Nam, we will determine the early diagnostic sensitivity, specificity, positive and negative predictive values of two NS1 diagnostic tests in severe dengue cases.\n\nThe study is intended to develop a prognostic algorithm for the early identification of severe dengue cases.\n\nRoutine demographic, haematological and biochemical laboratory markers will be utilized to derive a prognostic algorithm that is clinically-useful for guiding patient triage and interventions.\n\nWe hope to discover and evaluate new early biomarkers of severe dengue and will evaluate candidate host response molecules and virological markers for their prognostic value.\n\nWe further plan to understand the phylogeography of DENV in the super-urban setting of HCMC.\n\nWe will use genome scale sequencing of DENV together with geospatial information on the residential addresses of patients to better understand transmission dynamics in space and time in a high transmission super-urban district of HCMC and thereby identify opportunities for public health interventions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '1 Year', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient presenting to outpatient department of participating hospitals with symptoms of dengue fever', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical suspicion of dengue\n* Axillary temperature \\>=37.5C\n* Less than 72hrs of fever\n* Resident in Ho Chi Minh City\n* 1-15 yrs of age\n* Accompanying family member or guardian has a mobile phone\n* Written informed consent\n\nExclusion Criteria:\n\n* Any patient who the attending physician believes is unlikely to be able to attend follow-up\n* Any patient in who the attending physician believes another diagnosis is more likely.'}, 'identificationModule': {'nctId': 'NCT01421732', 'briefTitle': 'Laboratory Diagnosis and Prognosis of Severe Dengue', 'organization': {'class': 'OTHER', 'fullName': 'Oxford University Clinical Research Unit, Vietnam'}, 'officialTitle': 'Laboratory Diagnosis and Prognosis of Severe Dengue', 'orgStudyIdInfo': {'id': '13DX'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Suspected dengue fever', 'description': 'Children aged 1-15 presenting at participating hospitals with symptoms of dengue fever'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ho Chi Minh City', 'state': 'Ho Chi Minh', 'country': 'Vietnam', 'facility': 'Hospital for Tropical Diseases', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'overallOfficials': [{'name': 'Cameron Simmons, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oxford University Clinical Research Unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oxford University Clinical Research Unit, Vietnam', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam', 'class': 'OTHER'}, {'name': "Children's Hospital Number 1, Ho Chi Minh City, Vietnam", 'class': 'OTHER'}, {'name': "Number 2 Children's Hospital, Ho Chi Minh City", 'class': 'OTHER'}, {'name': 'Tien Giang Provincial Hospital, Tien Giang, Viet Nam', 'class': 'UNKNOWN'}, {'name': 'Red Cross Clinic Of District 8', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}