Mycoplasma Species and the Genitourinary System
Are Mycoplasma Species Associated With Disease in the Genitourinary System of Male and Female Patients Attending Sexual Health Clinics or Are They Bacterial Commensals?
1 other identifier
observational
1,000
1 country
1
Brief Summary
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2019
CompletedFirst Submitted
Initial submission to the registry
December 16, 2019
CompletedFirst Posted
Study publicly available on registry
January 11, 2022
CompletedJanuary 11, 2022
December 1, 2019
6 months
December 16, 2019
December 23, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
M. hominis and disease
Number of symptomatic participants with Mycoplasma infections
6 months
Secondary Outcomes (10)
M.hominis and drug use
6 months
M.hominis and number of sexual contacts
6 months
M.hominis and miscarriage
6 months
M.hominis and abortion
6 months
M.hominis and anal sex
6 months
- +5 more secondary outcomes
Study Arms (1)
myco well participants
Retrospective analysis of patient records. No new patients recruited.
Interventions
Retrospective analysis of records of recruits to a previous mycoplasma study.
Eligibility Criteria
Patients who are sexually active and attending a walk-in sexual health clinic in the UK.
You may qualify if:
- Sexually active participants aged 18 to 100 years
- Participants can give informed consent in writing.
You may not qualify if:
- Patients who have been sexually assault.
- Participants who cannot give informed consent in writing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cwm Taf University Health Board (NHS)lead
- Cardiff Universitycollaborator
Study Sites (1)
Cwm Taf Morgannwg University Health board
Pontypridd, CF37 1LB, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2019
First Posted
January 11, 2022
Study Start
April 5, 2019
Primary Completion
October 5, 2019
Study Completion
October 5, 2019
Last Updated
January 11, 2022
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share