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?

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.

Study Overview

• Status: Completed
• Conditions: Sexually Transmitted Diseases, Bacterial
• Intervention / Treatment: Other: Test:mycoplasma

Detailed Description

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).

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.

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• United Kingdom
  • Pontypridd, United Kingdom, CF37 1LB
    • Cwm Taf Morgannwg University Health Board

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who are sexually active and attending a walk-in sexual health clinic in the UK.

Description

Inclusion Criteria:

• Sexually active participants aged 18 to 100 years
• Participants can give informed consent in writing.

Exclusion Criteria:

• Patients who have been sexually assault.
• Participants who cannot give informed consent in writing.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
myco well participants; Retrospective analysis of patient records. No new patients recruited.	Other: Test:mycoplasma; Retrospective analysis of records of recruits to a previous mycoplasma study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
M. hominis and disease	Number of symptomatic participants with Mycoplasma infections	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
M.hominis and drug use	Number of patients with Mycoplasma infection and drug use	6 months
M.hominis and number of sexual contacts	Number of patients with Mycoplasma infection who have more than 2 sexual partners in 3 months	6 months
M.hominis and miscarriage	Number of patients with Mycoplasma infection who have a history of miscarriage	6 months
M.hominis and abortion	Number of patients with Mycoplasma infection who have a history of abortion in the last 5 years	6 months
M.hominis and anal sex	Number of patients with Mycoplasma infection who perform anal sex	6 months
M.hominis and unprotected sex	Number of patients with Mycoplasma infection who have sex without condom use	6 months
M.hominis and contraception	Number of patients with Mycoplasma infection while taking hormonal contraception	6 months
M.hominis and men who have sex with men	Number of patients with Mycoplasma infection and are men that have sex with men	6 months
M.hominis and commercial sex workers	Number of patients with Mycoplasma infection who have sex with commercial sex workers	6 months
M.hominis and chemsex	Number of patients with Mycoplasma infection who have chemsex	6 months

Collaborators and Investigators

• Sponsor: Cwm Taf University Health Board (NHS)
• Collaborators: Cardiff University

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2019
• Primary Completion (Actual): October 5, 2019
• Study Completion (Actual): October 5, 2019

Study Registration Dates

• First Submitted: December 16, 2019
• First Submitted That Met QC Criteria: December 23, 2021
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 23, 2021
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases; Sexually Transmitted Diseases, Bacterial
• Other Study ID Numbers: CT 253889

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No