Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
Study NCT ID:
NCT05186792
Status:
COMPLETED
Last Update Posted:
2022-01-11
First Post:
2019-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mycoplasma Species and the Genitourinary System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015231', 'term': 'Sexually Transmitted Diseases, Bacterial'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-10-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-23', 'studyFirstSubmitDate': '2019-12-16', 'studyFirstSubmitQcDate': '2021-12-23', 'lastUpdatePostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'M. hominis and disease', 'timeFrame': '6 months', 'description': 'Number of symptomatic participants with Mycoplasma infections'}], 'secondaryOutcomes': [{'measure': 'M.hominis and drug use', 'timeFrame': '6 months', 'description': 'Number of patients with Mycoplasma infection and drug use'}, {'measure': 'M.hominis and number of sexual contacts', 'timeFrame': '6 months', 'description': 'Number of patients with Mycoplasma infection who have more than 2 sexual partners in 3 months'}, {'measure': 'M.hominis and miscarriage', 'timeFrame': '6 months', 'description': 'Number of patients with Mycoplasma infection who have a history of miscarriage'}, {'measure': 'M.hominis and abortion', 'timeFrame': '6 months', 'description': 'Number of patients with Mycoplasma infection who have a history of abortion in the last 5 years'}, {'measure': 'M.hominis and anal sex', 'timeFrame': '6 months', 'description': 'Number of patients with Mycoplasma infection who perform anal sex'}, {'measure': 'M.hominis and unprotected sex', 'timeFrame': '6 months', 'description': 'Number of patients with Mycoplasma infection who have sex without condom use'}, {'measure': 'M.hominis and contraception', 'timeFrame': '6 months', 'description': 'Number of patients with Mycoplasma infection while taking hormonal contraception'}, {'measure': 'M.hominis and men who have sex with men', 'timeFrame': '6 months', 'description': 'Number of patients with Mycoplasma infection and are men that have sex with men'}, {'measure': 'M.hominis and commercial sex workers', 'timeFrame': '6 months', 'description': 'Number of patients with Mycoplasma infection who have sex with commercial sex workers'}, {'measure': 'M.hominis and chemsex', 'timeFrame': '6 months', 'description': 'Number of patients with Mycoplasma infection who have chemsex'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sexually Transmitted Diseases, Bacterial']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the presence of Mycoplasma hominis bacteria is associated with Bacterial vaginosis (BV), non-gonococcal urethritis (NGU) or vaginitis in patients attending sexual health clinic. Patients were participants of the MYCO WELL D-ONE study. Ethics for this follow-on pathway-to-portfolio study (IRAS:253889) is now approved by NRES and HCRW.\n\nThe important primary aim of this study is to determine if Mycoplasma hominis (M.hominis) is associated with BV, NGU and vaginitis in the genitourinary system of patients or if they are bacterial commensals. This is important proof of concept work. The secondary aim for this research is to determine if there are clinical and social parameters that are associated with Mycoplasma infection.\n\nPreliminary analysis of 100 patients yielded pilot data suggesting M.hominis is strongly associated with BV, NGU and vaginitis. We aim to consolidate these findings by expansion to 1000 patients from our completed MYCOWELL D-ONE study.', 'detailedDescription': 'The clinical study site is The Department of Sexual Health, Dewi Sant Hospital, Cwm Taf University Health Board. This study will retrospectively examine the clinical notes of consented participants (IRAS project ID:253889) in the MYCO WELL D-ONE study (IRAS project ID:230693).\n\nNotes will be identified by the sexual health clinic number. The clinic proforma records the following parameters:\n\n1. Gender the patient identifies with\n2. Age of the patient when the MYCO WELL D-ONE study sample collected\n3. Symptoms and signs that were recorded in the patient notes e.g. BV/NGU\n4. Previous sexually transmitted infections diagnosed\n5. Drug history\n6. Treatments the patient received\n7. Sexual history e.g. type of sexual activity On completion, he parameters associated with positive M.hominis result; bacteria load quantification/antimicrobial resistance) and statistical analysis will be examined as below. I Statistical analysis This will be performed on anonymised data. The primary outcome measure of this study is to determine if M.hominis is associated with BV, NGU and vaginitis in the genitourinary system of patients or if it is a bacterial commensal. The secondary outcome for this research is to determine if there are clinical and social parameters that are associated with M.hominis infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are sexually active and attending a walk-in sexual health clinic in the UK.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sexually active participants aged 18 to 100 years\n* Participants can give informed consent in writing.\n\nExclusion Criteria:\n\n* Patients who have been sexually assault.\n* Participants who cannot give informed consent in writing.'}, 'identificationModule': {'nctId': 'NCT05186792', 'briefTitle': 'Mycoplasma Species and the Genitourinary System', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Cwm Taf University Health Board (NHS)'}, 'officialTitle': 'Are Mycoplasma Species Associated With Disease in the Genitourinary System of Male and Female Patients Attending Sexual Health Clinics or Are They Bacterial Commensals?', 'orgStudyIdInfo': {'id': 'CT 253889'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'myco well participants', 'description': 'Retrospective analysis of patient records. No new patients recruited.', 'interventionNames': ['Other: Test:mycoplasma']}], 'interventions': [{'name': 'Test:mycoplasma', 'type': 'OTHER', 'description': 'Retrospective analysis of records of recruits to a previous mycoplasma study.', 'armGroupLabels': ['myco well participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CF37 1LB', 'city': 'Pontypridd', 'country': 'United Kingdom', 'facility': 'Cwm Taf Morgannwg University Health board', 'geoPoint': {'lat': 51.6021, 'lon': -3.34211}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cwm Taf University Health Board (NHS)', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Cardiff University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}