- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04954495
Sexually Transmitted Infections With Mycoplasma Genitalium: Epidemiological, Clinical, Microbiological, Therapeutic Aspects (IST_MG)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Julie Lourtet
- Phone Number: +33 144127420
- Email: jlourtet@ghpsj.fr
Study Locations
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-
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Paris, France, 75014
- Recruiting
- Groupe Hospitalier Paris Saint-Joseph
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Contact:
- Julie Lourtet
- Phone Number: +33 144127420
- Email: jlourtet@ghpsj.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical forms of these anorectal infection
Time Frame: Day 1
|
This outcome corresponds to the clinical presentation : prevalence of clinical signs [fever (Yes/no), ulcerations (yes/no), purulent proctisis (yes/no), erythematosus proctisis (yes/no), condyloma (yes/no)].
|
Day 1
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julie Lourtet, Fondation Hôpital Saint-Joseph
Publications and helpful links
General Publications
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- IST_MG
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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