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NCT Number: NCT05186792

Mycoplasma Species and the Genitourinary System

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.

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Key information

Conditions

Sexually Transmitted Diseases, Bacterial Bacterial Infections Bacterial Infections and Mycoses Communicable Diseases Disease Attributes Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Urogenital Diseases

Age range

16 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cwm Taf Morgannwg University Health board

Pontypridd, CF37 1LB, United Kingdom

About this study

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:

  • Gender the patient identifies with
  • Age of the patient when the MYCO WELL D-ONE study sample collected
  • Symptoms and signs that were recorded in the patient notes e.g. BV/NGU
  • Previous sexually transmitted infections diagnosed
  • Drug history
  • Treatments the patient received
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Test:mycoplasma

Other

Retrospective analysis of records of recruits to a previous mycoplasma study.

Primary outcomes

  1. M. hominis and disease

    Time frame: 6 months

    Number of symptomatic participants with Mycoplasma infections

Secondary outcomes

  1. M.hominis and drug use

    Time frame: 6 months

    Number of patients with Mycoplasma infection and drug use

  2. M.hominis and number of sexual contacts

    Time frame: 6 months

    Number of patients with Mycoplasma infection who have more than 2 sexual partners in 3 months

  3. M.hominis and miscarriage

    Time frame: 6 months

    Number of patients with Mycoplasma infection who have a history of miscarriage

  4. M.hominis and abortion

    Time frame: 6 months

    Number of patients with Mycoplasma infection who have a history of abortion in the last 5 years

  5. M.hominis and anal sex

    Time frame: 6 months

    Number of patients with Mycoplasma infection who perform anal sex

  6. M.hominis and unprotected sex

    Time frame: 6 months

    Number of patients with Mycoplasma infection who have sex without condom use

  7. M.hominis and contraception

    Time frame: 6 months

    Number of patients with Mycoplasma infection while taking hormonal contraception

  8. M.hominis and men who have sex with men

    Time frame: 6 months

    Number of patients with Mycoplasma infection and are men that have sex with men

  9. M.hominis and commercial sex workers

    Time frame: 6 months

    Number of patients with Mycoplasma infection who have sex with commercial sex workers

  10. M.hominis and chemsex

    Time frame: 6 months

    Number of patients with Mycoplasma infection who have chemsex

Sponsors and collaborators

Lead sponsor

Cwm Taf University Health Board (NHS)

Other Gov

Collaborators

  • Cardiff University

Registry information

Official study 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?

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 11, 2022
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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