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

Primary Purpose

Mycoplasma Genitalium Infection

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Vaginal self-sampling
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mycoplasma Genitalium Infection focused on measuring Mycoplasma genitalium, abortion, clearance, IST

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • CHU Bordeaux

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vaginal self-sampling

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
April 7, 2021
Last Updated
April 27, 2023
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT04841408
Brief Title
Prospective, Monocentric, Interventional Study on Spontaneous Vaginal Clearance of Mycoplasma Genitalium
Acronym
MYCOCLEAR
Official Title
Prospective, Monocentric, Interventional Study on Spontaneous Vaginal Clearance of Mycoplasma Genitalium
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 5, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
February 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycoplasma Genitalium Infection
Keywords
Mycoplasma genitalium, abortion, clearance, IST

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Vaginal 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)
Allocation
N/A
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vaginal self-sampling
Arm Type
Experimental
Arm Description
Vaginal self-sampling performed by the patient at the follow-up visit at 3 weeks and remote follow-up at 9 weeks.
Intervention Type
Other
Intervention Name(s)
Vaginal self-sampling
Intervention Description
Vaginal self-sampling performed by the patient at the follow-up visit at 3 weeks and remote follow-up at 9 weeks.
Primary Outcome Measure Information:
Title
clearance at week 3
Description
The clearance will be defined by a negative PCR test for M. genitalium in the vaginal sample taken at week 3.
Time Frame
Week 3
Secondary Outcome Measure Information:
Title
clearance at week 9
Description
The clearance defined by a negative PCR test for M. genitalium in the vaginal sample taken at week 9.
Time Frame
Week 9
Title
Prevalence of N. gonorrhoeae infections
Description
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.
Time Frame
Week 3, Week 9
Title
Prevalence of C. trachomatis infections
Description
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.
Time Frame
Week 3, Week 9
Title
Prevalence of M. genitalium infections
Description
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.
Time Frame
Week 3, Week 9
Title
patient's sex life
Description
patient's sex life, assessed by a self-questionnaire
Time Frame
Week 3, Week 9

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
CHU Bordeaux
City
Bordeaux
Country
France

12. IPD Sharing Statement

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

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