Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-02-24 @ 8:48 AM
Study NCT ID:
NCT02898402
Status:
COMPLETED
Last Update Posted:
2016-09-13
First Post:
2016-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Seroprevalence and Risk Factors of Coxiella Burnetii (Q Fever) in the South of Reunion Island
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011778', 'term': 'Q Fever'}], 'ancestors': [{'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-08', 'studyFirstSubmitDate': '2016-09-08', 'studyFirstSubmitQcDate': '2016-09-08', 'lastUpdatePostDateStruct': {'date': '2016-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of Coxiella burnetii infection in general population in the south of Reunion island', 'timeFrame': 'at inclusion', 'description': 'Q fever seroprevalence obtained from blood samples taken on pregnant women hospitalised for delivery will be used to extrapolate to Reunion island general population Q fever seroprevalence.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['q Fever']}, 'descriptionModule': {'briefSummary': 'Emergent and infectious diseases are a public health priority on Reunion Island. Amongst public health threats, the infection due to Coxiella burnetii (Q fever) seems to have appeared on Reunion island in 2007 with two hospitalised confirmed cases (one death) and one probable case with a goat farmer.\n\nAccording to the investigator, the diffusion of C. burnetti is more ancient and such diagnosis have been made in the last 30 years with 80 positive serologies identified between 2005 and 2011.\n\nConsidering the high epidemic power of this disease, its often silent clinical expression and its life-threatening condition, the principal investigator wishes to perform a sero-epidemiological study in order to establish or to reject the risk of emergence of Q fever in Reunion island.\n\nThe study will be performed on pregnant women because Q fever is responsible for particular complications during pregnancy and because the number of pregnancy followed on Reunion island is stable from one year to the other. The pregnant women population presenting the same exposure criteria as the general population, this population will be used to extrapolate to the general population of the island.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pregnant women coming to hospital for delivery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all pregnant women coming to the two maternity hospitals located in the south of Reunion island during inclusion period who have been informed and gave consent to participate to the study.\n\nExclusion Criteria:\n\n* women aged less than 18 years old.\n* women who did not give their consent\n* women for whom it is not possible to perform the blood sample.'}, 'identificationModule': {'nctId': 'NCT02898402', 'acronym': 'E-Q-RUN', 'briefTitle': 'Study on Seroprevalence and Risk Factors of Coxiella Burnetii (Q Fever) in the South of Reunion Island', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de la Réunion'}, 'officialTitle': 'Study on Seroprevalence and Risk Factors of Coxiella Burnetii (Q Fever) in the South of Reunion Island', 'orgStudyIdInfo': {'id': '2013/CHU/04'}}, 'armsInterventionsModule': {'interventions': [{'name': 'blood sample and questionnaire', 'type': 'PROCEDURE', 'description': 'In addition to normal blood sample performed at entry before delivery, an extra 5 ml blood sample will be taken to establish Q fever serodiagnosis and a short questionnaire will be filled in for clinical and epidemiological data.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de la Réunion', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}