Clinical trial NCT05186792: Mycoplasma Species and the Genitourinary System
Official title: Are Mycoplasma Species Associated With Disease in the Genitourinary System of Male and Female Patients Attending Sexual Health Clinics or Are They Bacterial Commensals?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexually Transmitted Diseases, Bacterial
Lead sponsor: Cwm Taf University Health Board (NHS)
Sponsor class: OTHER_GOV
Collaborators: name: Cardiff University
First posted: 2022-01-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are sexually active and attending a walk-in sexual health clinic in the UK.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: M. hominis and disease
timeFrame: 6 months
Secondary outcomes:
measure: M.hominis and drug use
timeFrame: 6 months
measure: M.hominis and number of sexual contacts
timeFrame: 6 months
measure: M.hominis and miscarriage
timeFrame: 6 months
measure: M.hominis and abortion
timeFrame: 6 months
measure: M.hominis and anal sex
timeFrame: 6 months
measure: M.hominis and unprotected sex
timeFrame: 6 months
measure: M.hominis and contraception
timeFrame: 6 months
measure: M.hominis and men who have sex with men
timeFrame: 6 months
measure: M.hominis and commercial sex workers
timeFrame: 6 months
measure: M.hominis and chemsex
timeFrame: 6 months
Other outcomes:
Locations:
city: Pontypridd
country: United Kingdom
facility: Cwm Taf Morgannwg University Health board
Study officials:
References: