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Mycoplasma Species and the Genitourinary System

NCT05186792 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2022-01-11

No results posted yet for this study

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.

Conditions

  • Sexually Transmitted Diseases, Bacterial

Interventions

OTHER

Test:mycoplasma

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

Sponsors & Collaborators

  • Cardiff University

    collaborator OTHER

  • Cwm Taf University Health Board (NHS)

    lead OTHER_GOV

Eligibility

Min Age
16 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-05
Primary Completion
2019-10-05
Completion
2019-10-05

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05186792 on ClinicalTrials.gov