Improving the Diagnosis of Sexually Transmitted Infections in Emergency Rooms
Primary Purpose
Sexually Transmitted Infection
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Anal swab
Sponsored by
About this trial
This is an interventional diagnostic trial for Sexually Transmitted Infection
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
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients admitted for sexually transmitted infection
Arm Description
Outcomes
Primary Outcome Measures
Percentage of patients with a confirmed etiological diagnosis of sexually transmitted infection
Secondary Outcome Measures
Full Information
NCT ID
NCT02868346
First Posted
August 11, 2016
Last Updated
April 20, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02868346
Brief Title
Improving the Diagnosis of Sexually Transmitted Infections in Emergency Rooms
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 29, 2013 (Actual)
Primary Completion Date
February 8, 2019 (Actual)
Study Completion Date
October 26, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Infection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
303 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients admitted for sexually transmitted infection
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Anal swab
Primary Outcome Measure Information:
Title
Percentage of patients with a confirmed etiological diagnosis of sexually transmitted infection
Time Frame
1 day
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine GEINDRE
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Improving the Diagnosis of Sexually Transmitted Infections in Emergency Rooms
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