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

Not Applicable

Completed

• Conditions: Mycoplasma Genitalium Infection
• Interventions: Other: Vaginal self-sampling

• Registration Number: NCT04841408
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2021-04-05
• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-12
• Primary Completion: 2023-01-31
• Study Completion: 2023-02-21
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-27
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 69

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Prevalence of M. genitalium infections	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.
Prevalence of N. gonorrhoeae infections	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.
Prevalence of C. trachomatis infections	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.
clearance at week 9	Week 9	The clearance defined by a negative PCR test for M. genitalium in the vaginal sample taken at week 9.
patient's sex life	Week 3, Week 9	patient's sex life, assessed by a self-questionnaire

Trial Locations

Locations (1)

CHU Bordeaux; 🇫🇷 Bordeaux, France