Bacterial Ano-rectitis Sexually Transmitted in a Speciali... | NCT03625713

Studies
Bacterial Ano-rectitis Sexually Transmitted in a Specialized Consultation Center

NCT03625713

Sponsor

Fondation Hôpital Saint-Joseph

Status

Unknown status

Last Update Posted

Apr 27, 2023Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Ano-Rectal Infection Bacterial Nos

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 20, 2018Actual

Primary Completion Date

Jun 2, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Jul 13, 2018

First Submission Date that Met QC Criteria

Aug 9, 2018

First Posted Date

Aug 10, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2023

Last Update Posted Date

Apr 27, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vincent De Parades, MD	Contact	0144127469		vdeparades@hpsj.fr

Overall Officials

Name	Affiliation	Role
Vincent De Parades, MD	Fondation Hôpital Saint-Joseph	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groupe Hospitalier Paris Saint-Joseph	Recruiting	Paris		75014	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided