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

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

Study Overview

• Status: Completed
• Conditions: Mycoplasma Genitalium Infection
• Intervention / Treatment: Other: Vaginal self-sampling

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 Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • CHU Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
patient's sex life	patient's sex life, assessed by a self-questionnaire	Week 3, Week 9
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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2021
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): February 21, 2023

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: April 7, 2021
• First Posted (Actual): April 12, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: abortion; Mycoplasma genitalium; clearance; IST
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Pleural Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Pleurisy; Mycoplasmatales Infections; Pleuropneumonia; Mycoplasma Infections
• Other Study ID Numbers: CHUBX 2021/06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No