Improving the Diagnosis of Sexually Transmitted Infection... | NCT02868346

Studies
Improving the Diagnosis of Sexually Transmitted Infections in Emergency Rooms

NCT02868346

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Completed

Last Update Posted

Apr 21, 2023Actual

Enrollment

303Actual

Phase

Not Applicable

Conditions

Sexually Transmitted Infection

Interventions

Anal swab

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

ID	Type	Description	Link
2012-A01599-34	Other Identifier	ANSM

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 29, 2013Actual

Primary Completion Date

Feb 8, 2019Actual

Completion Date

Oct 26, 2022Actual

First Submitted Date

Aug 11, 2016

First Submission Date that Met QC Criteria

Aug 11, 2016

First Posted Date

Aug 16, 2016Estimated

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 20, 2023

Last Update Posted Date

Apr 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of sexually transmitted infections caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC sexually infection transmitted tests .

Most sexually transmitted infections can be diagnosed from an anal swab which is not routinely performed. In this study, we suggest to test the hypothesis that anal swab in addition to the routine genital swab would increase by at least 5% the diagnosis capacity of sexually transmitted infections after the POC tests.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

303Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients admitted for sexually transmitted infection	Experimental		Other: Anal swab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anal swab	Other		Patients admitted for sexually transmitted infection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients with a confirmed etiological diagnosis of sexually transmitted infection		1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient admitted for sexually transmitted infection in emergency room requiring a microbiological examination with a "Sexually Transmitted Infection POC kit"
Patient who freely signed the informed consent form
Patient affiliated to a social security regime

Exclusion criteria

Pregnant or breastfeeding women
Adult patient under guardianship
Patient deprived with liberty under court order
Patient refusing or unable to sign the informed consent form

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Catherine GEINDRE	Assistance Publique Hôpitaux de Marseille	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assistance Publique Hopitaux de Marseille		Marseille			France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012749	Sexually Transmitted Diseases

Ancestor Terms

ID	Term
D003141	Communicable Diseases
D007239	Infections
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided