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

Mycoplasma Genitalium Infection Clinical Trial

— MYCOCLEAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04841408
• Other study ID #: CHUBX 2021/06
• Status: Completed
• Phase: N/A
• Start date: April 5, 2021
• Est. completion date: February 21, 2023

Study information

• Verified date: April 2023
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: February 21, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mycoplasma Genitalium Infection
• Mycoplasma Infections
• Pleuropneumonia

Intervention

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.

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clearance at week 3	The clearance will be defined by a negative PCR test for M. genitalium in the vaginal sample taken at week 3.	Week 3
Secondary	clearance at week 9	The clearance defined by a negative PCR test for M. genitalium in the vaginal sample taken at week 9.	Week 9
Secondary	Prevalence of N. gonorrhoeae infections	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.	Week 3, Week 9
Secondary	Prevalence of C. trachomatis infections	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.	Week 3, Week 9
Secondary	Prevalence of M. genitalium infections	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.	Week 3, Week 9
Secondary	patient's sex life	patient's sex life, assessed by a self-questionnaire	Week 3, Week 9