Sexually Transmitted Diseases, BacterialNCT05186792
Mycoplasma Species and the Genitourinary System
An observational study of Sexually Transmitted Diseases, Bacterial, run by Cwm Taf University Health Board (NHS) at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 16 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Diseases, Bacterial
- What is being tested?
- Test:mycoplasma
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Apr 2019to 5 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients who are sexually active and attending a walk-in sexual health clinic in the UK.
Who may be able to join
- Sexually active participants aged 18 to 100 years
- Participants can give informed consent in writing.
Who cannot join
- Patients who have been sexually assault.
- Participants who cannot give informed consent in writing.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cwm Taf Morgannwg University Health board
Pontypridd, CF37 1LB
About this study
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?
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.
Read the 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:
- 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.
- Conditions
- Sexually Transmitted Diseases, Bacterial
- Being tested
- Test:mycoplasma
- Medical subject headings
- Sexually Transmitted Diseases, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test:mycoplasmaOther
Retrospective analysis of records of recruits to a previous mycoplasma study.
| Study group | Role | What they receive |
|---|---|---|
| myco well participants | Retrospective analysis of patient records. No new patients recruited. Receives: Other: Test:mycoplasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
M. hominis and disease
Number of symptomatic participants with Mycoplasma infections
Measured: 6 months
Secondary outcomes (10)
M.hominis and drug use
Number of patients with Mycoplasma infection and drug use
Measured: 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
Measured: 6 months
M.hominis and miscarriage
Number of patients with Mycoplasma infection who have a history of miscarriage
Measured: 6 months
M.hominis and abortion
Number of patients with Mycoplasma infection who have a history of abortion in the last 5 years
Measured: 6 months
M.hominis and anal sex
Number of patients with Mycoplasma infection who perform anal sex
Measured: 6 months
M.hominis and unprotected sex
Number of patients with Mycoplasma infection who have sex without condom use
Measured: 6 months
M.hominis and contraception
Number of patients with Mycoplasma infection while taking hormonal contraception
Measured: 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
Measured: 6 months
M.hominis and commercial sex workers
Number of patients with Mycoplasma infection who have sex with commercial sex workers
Measured: 6 months
M.hominis and chemsex
Number of patients with Mycoplasma infection who have chemsex
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start5 Apr 2019
- Primary completion5 Oct 2019
- Study completion5 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted Diseases, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cwm Taf University Health Board (NHS)
- Sponsor type
- Other government
- Collaborators
- Cardiff University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186792
- Sponsor's protocol ID
- CT 253889
- Status last verified
- Dec 2019
- First submitted
- 16 Dec 2019
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT05186792
- Acronym / sponsor ID
- CT 253889
- Conditions
- Sexually Transmitted Diseases, Bacterial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Cwm Taf University Health Board (NHS)Other government
- Collaborators
- Cardiff University
- Study start
- 5 Apr 2019 (actual)
- Primary completion
- 5 Oct 2019 (actual)
- Study completion
- 5 Oct 2019 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| myco well participants | – | Other: Test:mycoplasmaRetrospective analysis of patient records. No new patients recruited. |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who are sexually active and attending a walk-in sexual health clinic in the UK.
Key inclusion criteria (2 listed)
- Sexually active participants aged 18 to 100 years
- Participants can give informed consent in writing.
Key exclusion criteria (2 listed)
- Patients who have been sexually assault.
- Participants who cannot give informed consent in writing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test:mycoplasmaRetrospective analysis of records of recruits to a previous mycoplasma study. | Other | myco well participants |
Primary outcome
M. hominis and disease
Time frame: 6 months
Number of symptomatic participants with Mycoplasma infections
10 secondary outcomes
M.hominis and drug use
Time frame: 6 months
M.hominis and number of sexual contacts
Time frame: 6 months
M.hominis and miscarriage
Time frame: 6 months
M.hominis and abortion
Time frame: 6 months
M.hominis and anal sex
Time frame: 6 months
M.hominis and unprotected sex
Time frame: 6 months
M.hominis and contraception
Time frame: 6 months
M.hominis and men who have sex with men
Time frame: 6 months
M.hominis and commercial sex workers
Time frame: 6 months
M.hominis and chemsex
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sexually Transmitted Diseases, Bacterial, run by Cwm Taf University Health Board (NHS) at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
M. hominis and disease (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022; AzTrials last refreshed its copy on 6 Nov 2026.