Improving the Diagnosis of Sexually Transmitted Infections in Emergency Rooms

Sponsor

Assistance Publique Hopitaux De Marseille (Other)

Overall Status

Unknown status

CT.gov ID

NCT02868346

Collaborator

(none)

4,320

Enrollment

Location

Arm

Duration (Months)

56.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sexually Transmitted Infection	Other: Anal swab	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

4320 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Study Start Date :

Mar 1, 2013

Anticipated Primary Completion Date :

Feb 1, 2019

Anticipated Study Completion Date :

Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients admitted for sexually transmitted infection	Other: Anal swab

Arm

Intervention/Treatment

Experimental: Patients admitted for sexually transmitted infection

Other: Anal swab

Outcome Measures

Primary Outcome Measures

Percentage of patients with a confirmed etiological diagnosis of sexually transmitted infection [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique Hopitaux de Marseille	Marseille		France

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Study Director: Catherine GEINDRE, Assistance Publique Hôpitaux de Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique Hopitaux De Marseille

ClinicalTrials.gov Identifier:

NCT02868346

Other Study ID Numbers:

2012-50
2012-A01599-34

First Posted:

Aug 16, 2016

Last Update Posted:

Aug 17, 2016

Last Verified:

Aug 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Infections

Sexually Transmitted Diseases

Study Results

No Results Posted as of Aug 17, 2016