Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT04287504
Status:
UNKNOWN
Last Update Posted:
2021-03-19
First Post:
2020-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Point-of-care Tests for Bacterial Vaginosis and Candidosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D016585', 'term': 'Vaginosis, Bacterial'}, {'id': 'D002177', 'term': 'Candidiasis'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-18', 'studyFirstSubmitDate': '2020-02-25', 'studyFirstSubmitQcDate': '2020-02-25', 'lastUpdatePostDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Test result of OSOM BVBLUE Test or SavvyCheck Vaginal Yeast Test', 'timeFrame': '10 minutes', 'description': 'Result of point-of-care test'}], 'secondaryOutcomes': [{'measure': 'Gestational age of delivery', 'timeFrame': 'approx. 6 months', 'description': 'To assess preterm delivery rate'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['point-of-care test', 'validation', 'preterm birth', 'bacterial vaginosis', 'candidosis'], 'conditions': ['Infection, Bacterial', 'Infection, Fungal', 'Preterm Birth']}, 'descriptionModule': {'briefSummary': 'Vaginal infection in early pregnancy is associated with an increased risk of spontaneous preterm delivery and late miscarriage. Most studies presume that vaginal infections are responsible for up to 40% of preterm birth. Although the causative microorganisms of vaginal infections are manifold, the three pathogens most commonly associated with vaginal infections are Gardnerella vaginalis, Candida albicans and Trichomonas vaginalis. The aim of this prospective study is the validation of the point-of-care tests OSOM BVBLUE for bacterial vaginosis and SavvyCheck Vaginal Yeast Test for candidosis in comparison to Gram stain.', 'detailedDescription': 'In the present study, it should be examined whether the OSOM BVBLUE for bacterial vaginosis and the SavvyCheck Vaginal Yeast Test for vaginal candidosis are superior, equal/comparable or inferior to diagnosis on Gram stained smears. The point-of-care-tests are potential tools for the adequate diagnosis of bacterial vaginosis and vaginal candidosis in early pregnancy, since the prevention of these infections, as well as the infection screening per se, have the potential to prevent preterm birth and reduce the rate of late abortion. Point-of-care-tests are easy to perform, relatively cheap, and widely available. Routine implementation of the tests would be an effective contribution to the reduction of preterm labor and late-onset mortality.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Recruitement will take place during routine birth registration at the obstetric outpatient clinic at the Department of Obstetrics and Gynecology at the Medical University of Vienna. All data will be collected anonymized and encoded with numbers. Pregnant women will be screened for asymptomatic and symptomatic vaginal infection via Gram stain as part of routine management. Vaginal smears will be assessed by sterile swabs from the lateral vaginal wall and posterior fornix vaginae. Two swabs will be collected. The second swab will be taken for study purposes to undergo the OSOM BVBLUE Test for bacterial vaginosis or the SavvyCheck Vaginal Yeast Test for vaginal candidosis.', 'genderDescription': 'pregnancy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Legal age (Participants must be 18 years or over)\n* Singleton pregnancy\n* No recent therapy with antibiotics within the last two weeks\n* No application of the following in the previous 72 hours before testing: vaginal ointments/crèmes, douches, spermicides, vaginal lubricants or feminine sprays\n\nExclusion criteria:\n\n* Age below 18 years\n* Multiple pregnancy\n* Recent treatment with antibiotics\n* Application of the following in the previous 72 hours: vaginal ointments/crèmes, douches, spermicides, vaginal lubricants or feminine sprays'}, 'identificationModule': {'nctId': 'NCT04287504', 'briefTitle': 'Point-of-care Tests for Bacterial Vaginosis and Candidosis', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Validation of the OSOM BVBLUE Test for Bacterial Vaginosis and the SavvyCheck Vaginal Yeast Test for Vaginal Candidosis: A Prospective Study', 'orgStudyIdInfo': {'id': '2115-2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Yeast, control', 'description': 'Women negative for vulvovaginal candidosis on Gram stain smear.', 'interventionNames': ['Diagnostic Test: SavvyCheck Vaginal Yeast Test']}, {'label': 'Yeast, study group', 'description': 'Women positive for vulvovaginal candidosis on Gram stain smear.', 'interventionNames': ['Diagnostic Test: SavvyCheck Vaginal Yeast Test']}, {'label': 'Bacterial vaginosis, control', 'description': 'Women negative for bacterial vaginosis on Gram stain smear.', 'interventionNames': ['Diagnostic Test: OSOM BVBLUE Test']}, {'label': 'Bacterial vaginosis, study group', 'description': 'Women positive for bacterial vaginosis on Gram stain smear.', 'interventionNames': ['Diagnostic Test: OSOM BVBLUE Test']}], 'interventions': [{'name': 'SavvyCheck Vaginal Yeast Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Point-of-care test for the detection of vaginal candidosis', 'armGroupLabels': ['Yeast, control', 'Yeast, study group']}, {'name': 'OSOM BVBLUE Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Point-of-care test for the detection of bacterial vaginosis', 'armGroupLabels': ['Bacterial vaginosis, control', 'Bacterial vaginosis, study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Philipp Foessleitner, MD BSc', 'role': 'CONTACT', 'email': 'philipp.foessleitner@meduniwien.ac.at', 'phone': '+43140400', 'phoneExt': '28220'}, {'name': 'Alex Farr, MD PhD', 'role': 'CONTACT', 'email': 'alex.farr@meduniwien.ac.at', 'phone': '+43140400', 'phoneExt': '28220'}, {'name': 'Herbert Kiss, MD MBA', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Medical University of Vienna, Dept. of Obstetrics and Gynecology', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Philipp Foessleitner, MD BSc', 'role': 'CONTACT', 'email': 'philipp.foessleitner@meduniwien.ac.at', 'phone': '+43140400', 'phoneExt': '28220'}, {'name': 'Alex Farr, MD PhD', 'role': 'CONTACT', 'email': 'alex.farr@meduniwien.ac.at', 'phone': '+43140400', 'phoneExt': '28220'}], 'overallOfficials': [{'name': 'Herbert Kiss, MD MBA', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical University of Vienna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'on request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Consultant Physician', 'investigatorFullName': 'Alex Farr, MD PhD', 'investigatorAffiliation': 'Medical University of Vienna'}}}}