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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bordeaux, France
- CHU Bordeaux
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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)
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.
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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
Time Frame: 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
Time Frame: 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.
|
Week 3, Week 9
|
|
Prevalence of C. trachomatis infections
Time Frame: 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.
|
Week 3, Week 9
|
|
Prevalence of M. genitalium infections
Time Frame: 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.
|
Week 3, Week 9
|
|
patient's sex life
Time Frame: Week 3, Week 9
|
patient's sex life, assessed by a self-questionnaire
|
Week 3, Week 9
|
|
clearance at week 9
Time Frame: 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2021/06
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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