Sexually Transmitted Infections With Mycoplasma Genitalium: Epidemiological, Clinical, Microbiological, Therapeutic Aspects

NCT ID: NCT04954495

Last Updated: 2023-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-17

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Infectious anorectitis is a poorly described clinical entity. Their epidemiology is poorly known, as are their clinical, diagnostic (diagnoses are regularly made in gastroenterology and new diagnostic tools are now available) and therapeutic aspects.

The proctology center of the Marie Thérèse Center is the leading proctology center in the Ile-de-France region both in terms of recruitment and reputation, and drains a large proportion of patients with anorectitis for specialized care. The clinical microbiology laboratory of the Saint Joseph Hospital Group is linked to the Marie Thérèse Center to provide its expertise in the microbiological and infectious aspects of the management of these infections.

In recent years, the analysis of data from this large population of patients referred to the Léopold Bellan proctology center for suspected ano-rectitis has revealed the pathogens Neisseria gonorrhoeae and/or Chlamydia trachomatis.

Mycoplasma genitalium (MG) is an emerging pathogen responsible for Sexually Transmitted Infections (STI) and has been described increasingly in recent years. Studies on this pathogen will allow to better identify risk factors and to target optimized prevention and therapeutic management strategies.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anorectal Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient whose age is ≥ 18 years
* Patients treated at the Centre de proctologie of the Centre de santé Marie-Thérèse or the GHPSJ (consultation and/or hospitalization) and for whom an anorectal swab will be taken for suspected infectious sexually transmitted ano-rectitis
* French-speaking patient

Exclusion Criteria

* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection
* Patient objecting to the use of his data for this research
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Julie Lourtet

Role: PRINCIPAL_INVESTIGATOR

Fondation Hôpital Saint-Joseph

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Groupe Hospitalier Paris Saint-Joseph

Paris, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Julie LOURTET

Role: CONTACT

144127420 ext. +33

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Julie Lourtet

Role: primary

144127420 ext. +33

References

Explore related publications, articles, or registry entries linked to this study.

Price MJ, Ades AE, De Angelis D, Welton NJ, Macleod J, Soldan K, Simms I, Turner K, Horner PJ. Risk of pelvic inflammatory disease following Chlamydia trachomatis infection: analysis of prospective studies with a multistate model. Am J Epidemiol. 2013 Aug 1;178(3):484-92. doi: 10.1093/aje/kws583. Epub 2013 Jun 27.

Reference Type BACKGROUND
PMID: 23813703 (View on PubMed)

Vieira VA, Avelino-Silva VI, Cerqueira NB, Costa DA, Costa PR, Vasconcelos RP, Madruga VR, Moreira RI, Hoagland B, Veloso VG, Grinsztejn B, Kallas EG; PrEP Brasil Study Team. Asymptomatic anorectal Chlamydia trachomatis and Neisseria gonorrhoeae infections are associated with systemic CD8+ T-cell activation. AIDS. 2017 Sep 24;31(15):2069-2076. doi: 10.1097/QAD.0000000000001580.

Reference Type BACKGROUND
PMID: 28692536 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IST_MG

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cerebral Toxoplasmosis and AIDS
NCT00803621 COMPLETED