Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1000 participants
OBSERVATIONAL
2019-04-05
2019-10-05
Brief Summary
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The 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.
Preliminary 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.
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Detailed Description
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Notes will be identified by the sexual health clinic number. The clinic proforma records the following parameters:
1. Gender the patient identifies with
2. Age of the patient when the MYCO WELL D-ONE study sample collected
3. Symptoms and signs that were recorded in the patient notes e.g. BV/NGU
4. Previous sexually transmitted infections diagnosed
5. Drug history
6. Treatments the patient received
7. 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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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myco well participants
Retrospective analysis of patient records. No new patients recruited.
Test:mycoplasma
Retrospective analysis of records of recruits to a previous mycoplasma study.
Interventions
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Test:mycoplasma
Retrospective analysis of records of recruits to a previous mycoplasma study.
Eligibility Criteria
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Inclusion Criteria
* Participants can give informed consent in writing.
Exclusion Criteria
* Participants who cannot give informed consent in writing.
16 Years
100 Years
ALL
Yes
Sponsors
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Cardiff University
OTHER
Cwm Taf University Health Board (NHS)
OTHER_GOV
Responsible Party
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Locations
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Cwm Taf Morgannwg University Health board
Pontypridd, , United Kingdom
Countries
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Other Identifiers
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CT 253889
Identifier Type: -
Identifier Source: org_study_id
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