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NCT Number: NCT04841408

Prospective, Monocentric, Interventional Study on Spontaneous Vaginal Clearance of Mycoplasma Genitalium

It is a prospective, monocentric, interventional study on spontaneous vaginal clearance of Mycoplasma genitalium.

The main objective is to evaluate the spontaneous vaginal clearance of M. genitalium in patients coming to perform a voluntary termination of pregnancy at the University Hospital of Bordeaux at 9 weeks after a vaginal sample positive for M. genitalium

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Key information

Conditions

Mycoplasma Genitalium Infection

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Bordeaux

Bordeaux, France

About this study

Mycoplasma genitalium is a bacterium that colonizes female genital tract and can be responsible for sexually transmitted infection . M. genitalium can cause cervicitis and more rarely high genital infections.

In the vast majority of cases, presence of M. genitalium is not accompanied by any symptoms and women do not develop disease. Natural history of M. genitalium infection is not well documented. Some studies have shown a natural clearance of infection in women. The published work mainly concerns patients at very high risk of sexually transmitted disease, but we do not have French data.

We propose to study the natural clearance of M. genitalium infection in patients consulting at the Orthogeny Centre of the University Hospital of Bordeaux. Results of this work will allow us to have a better knowledge of the natural history of M. genitalium infection.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient selected during the first consultation, pre-abortion, and having a vaginal swab positive to M. genitalium.
  • Patient hospitalized for an abortion at the University Hospital of Bordeaux.
  • An affiliated patient or beneficiary of a social security system.
  • Signing free and informed consent.

Exclusion criteria

  • Patient with vaginal co-infection with C. trachomatis.
  • Patient with symptoms of high genital infection.
  • Taking fluoroquinolones, macrolides or tetracyclines within 21 days of inclusion.
  • Patient under legal protection.

Treatment and study plan

Vaginal self-sampling

Other

Vaginal self-sampling performed by the patient at the follow-up visit at 3 weeks and remote follow-up at 9 weeks.

Primary outcomes

  1. clearance at week 3

    Time frame: Week 3

    The clearance will be defined by a negative PCR test for M. genitalium in the vaginal sample taken at week 3.

Secondary outcomes

  1. clearance at week 9

    Time frame: Week 9

    The clearance defined by a negative PCR test for M. genitalium in the vaginal sample taken at week 9.

  2. Prevalence of N. gonorrhoeae infections

    Time frame: Week 3, Week 9

    Prevalence of infections with N. gonorrhoeae calculated by making the ratio between the number of patients with a positive vaginal swab for N. gonorrhoeae compared to the total number of patients tested.

  3. Prevalence of C. trachomatis infections

    Time frame: Week 3, Week 9

    Prevalence of infections with C. trachomatis calculated by making the ratio between the number of patients with a positive vaginal swab for C. trachomatis compared to the total number of patients tested.

  4. Prevalence of M. genitalium infections

    Time frame: Week 3, Week 9

    Prevalence of infections with M. genitalium, calculated by making the ratio between the number of patients with a positive vaginal swab for M. genitalium compared to the total number of patients tested.

  5. patient's sex life

    Time frame: Week 3, Week 9

    patient's sex life, assessed by a self-questionnaire

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: MYCOCLEAR

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2021
Registry last updated
Apr 28, 2023

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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