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

University Hospital of Bordeaux

Status: Completed

Conditions: Mycoplasma Genitalium Infection

Treatments: Other: Vaginal self-sampling

Study type: Interventional

Funder types: Other

Identifiers

NCT04841408

CHUBX 2021/06

Details and patient eligibility

About

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

Full description

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.

Enrollment: 69 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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69 participants in 1 patient group

Vaginal self-sampling

Experimental group

Description:

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

Treatment:

Other: Vaginal self-sampling