Bacterial Ano-rectitis Sexually Transmitted in a Specialized Consultation Center (IST)

Epidemiological, Clinical, Microbiological and Therapeutic Aspects of Sexually Transmitted Bacterial Ano-rectitis in a Specialized Consultation Center

Infectious ano-rectitis is poorly described. Their epidemiology is poorly known, as are their clinical, diagnostic (diagnoses are regularly corrected in gastroenterology and new diagnostic tools are now available) and therapeutic aspects.

Analysis of data from this large population of patients referred to the proctology center for suspicion of Neisseria gonorrhoeae and / or Chlamydia trachomatis ano-rectitis will help identify risk factors and target prevention strategies and optimized therapeutic management.

Study Overview

• Status: Recruiting
• Conditions: Ano-Rectal Infection Bacterial Nos

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Vincent De Parades, MD; Phone Number: 0144127469; Email: vdeparades@hpsj.fr

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Groupe Hospitalier Paris Saint-Joseph
    • Contact: Hélène BEAUSSIER, PhD, PharmD; Phone Number: 0144127038; Email: crc@hpsj.fr

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

The study population corresponds to patients seen in hospital, in emergency consultation or programmed for a suspicion of infectious ano-rectitis and for whom a sampling for diagnostic purposes will be carried out and addressed in microbiology.

Description

Inclusion Criteria:

• Patient over the age of 18
• Patient consulting or hospitalized in the proctology center
• Patient for whom an anorectal sampling will be performed for suspicion of sexually transmitted infectious ano-rectitis

Exclusion Criteria:

• Patient's opposition to participate
• Patient deprived of liberty
• Patient under guardianship

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate 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

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Paris Saint Joseph

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2018
• Primary Completion (Anticipated): June 2, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: July 13, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): April 27, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections
• Other Study ID Numbers: IST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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