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NCT02868346 Clinical Trial

Improving the Diagnosis of Sexually Transmitted Infections in Emergency Rooms

Sexually Transmitted Infection Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02868346
Other study ID # 2012-50
Secondary ID 2012-A01599-34
Status Completed
Phase N/A
First received
Last updated
Start date March 29, 2013
Est. completion date October 26, 2022

Study information
Verified date April 2023
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 303
Est. completion date October 26, 2022
Est. primary completion date February 8, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Anal swab

Locations
Country Name City State
France Assistance Publique Hopitaux de Marseille Marseille

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patients with a confirmed etiological diagnosis of sexually transmitted infection 1 day
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