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

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Recruiting

CT.gov ID

NCT04841408

Collaborator

(none)

100

Enrollment

Location

Arm

14.5

Anticipated Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Mycoplasma Genitalium Infection	Other: Vaginal self-sampling	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Apr 5, 2021

Anticipated Primary Completion Date :

Jun 20, 2022

Anticipated Study Completion Date :

Jun 20, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: 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.

Arm

Intervention/Treatment

Experimental: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

clearance at week 3 [Week 3]
The clearance defined by a negative PCR test for M. genitalium in the vaginal sample taken at week 3.
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.
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.
patient's sex life [Week 3, Week 9]
patient's sex life, assessed by a self-questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.