Mycoplasma Species and the Genitourinary System

Sexually Transmitted Diseases, Bacterial Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05186792
• Other study ID #: CT 253889
• Status: Completed
• Start date: April 5, 2019
• Est. completion date: October 5, 2019

Study information

• Verified date: December 2019
• Source: Cwm Taf University Health Board (NHS)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: October 5, 2019
• Est. primary completion date: October 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sexually Transmitted Diseases
• Sexually Transmitted Diseases, Bacterial

Intervention

Other:
• Test:mycoplasma
Retrospective analysis of records of recruits to a previous mycoplasma study.

Locations

Country	Name	City	State
United Kingdom	Cwm Taf Morgannwg University Health board	Pontypridd

Sponsors (2)

Lead Sponsor	Collaborator
Cwm Taf University Health Board (NHS)	Cardiff University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	M. hominis and disease	Number of symptomatic participants with Mycoplasma infections	6 months
Secondary	M.hominis and drug use	Number of patients with Mycoplasma infection and drug use	6 months
Secondary	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
Secondary	M.hominis and miscarriage	Number of patients with Mycoplasma infection who have a history of miscarriage	6 months
Secondary	M.hominis and abortion	Number of patients with Mycoplasma infection who have a history of abortion in the last 5 years	6 months
Secondary	M.hominis and anal sex	Number of patients with Mycoplasma infection who perform anal sex	6 months
Secondary	M.hominis and unprotected sex	Number of patients with Mycoplasma infection who have sex without condom use	6 months
Secondary	M.hominis and contraception	Number of patients with Mycoplasma infection while taking hormonal contraception	6 months
Secondary	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
Secondary	M.hominis and commercial sex workers	Number of patients with Mycoplasma infection who have sex with commercial sex workers	6 months
Secondary	M.hominis and chemsex	Number of patients with Mycoplasma infection who have chemsex	6 months