NCT02868346

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2013

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 16, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2019

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2022

Completed
Last Updated

April 21, 2023

Status Verified

April 1, 2023

Enrollment Period

5.9 years

First QC Date

August 11, 2016

Last Update Submit

April 20, 2023

Conditions

Sexually Transmitted Infection

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with a confirmed etiological diagnosis of sexually transmitted infection

    1 day

Study Arms (1)

Patients admitted for sexually transmitted infection

EXPERIMENTAL
Other: Anal swab

Interventions

Anal swabOTHER
Patients admitted for sexually transmitted infection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, France

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Catherine GEINDRE

    Assistance Publique Hôpitaux de Marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2016

First Posted

August 16, 2016

Study Start

March 29, 2013

Primary Completion

February 8, 2019

Study Completion

October 26, 2022

Last Updated

April 21, 2023

Record last verified: 2023-04

Locations

FR(1)