Improving the Diagnosis of Diarrhoea in Emergency Rooms
Primary Purpose
Diarrhoea
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Nasopharyngeal Swab
Sponsored by
About this trial
This is an interventional diagnostic trial for Diarrhoea
Eligibility Criteria
Inclusion Criteria:
- Patient admitted at hospital for diarrhoea requiring, for the emergency physician, a microbiological examination with a "POC diarrhoea kit."
- Patient who has freely signed the informed written consent
- Patient affiliated to a social security scheme
Exclusion Criteria:
- Pregnant woman, parturient or nursing
- Adult major under guardianship
- Patient deprived of 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 with Diarrhoea
Arm Description
Patients admitted in emergency room with Diarrhoea
Outcomes
Primary Outcome Measures
Percentage of patients admitted in emergency rooms for diarrhoea with confirmed etiological diagnosis
Secondary Outcome Measures
Full Information
NCT ID
NCT02858609
First Posted
July 29, 2016
Last Updated
April 20, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02858609
Brief Title
Improving the Diagnosis of Diarrhoea in Emergency Rooms
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 20, 2013 (Actual)
Primary Completion Date
February 8, 2019 (Actual)
Study Completion Date
October 27, 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 diarrhoea caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC diarrhoea tests . This lab has discovered over 200 new species of bacteria in humans, including vector bacteria and opened the field of large Deoxyribonucleic Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribonucleic Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens described in POC laboratory, this study proposes to expand the etiological diagnosis strategy of diarrhoea after POC tests.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhoea
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
354 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with Diarrhoea
Arm Type
Experimental
Arm Description
Patients admitted in emergency room with Diarrhoea
Intervention Type
Other
Intervention Name(s)
Nasopharyngeal Swab
Primary Outcome Measure Information:
Title
Percentage of patients admitted in emergency rooms for diarrhoea with confirmed etiological diagnosis
Time Frame
1 day
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient admitted at hospital for diarrhoea requiring, for the emergency physician, a microbiological examination with a "POC diarrhoea kit."
Patient who has freely signed the informed written consent
Patient affiliated to a social security scheme
Exclusion Criteria:
Pregnant woman, parturient or nursing
Adult major under guardianship
Patient deprived of 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
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Improving the Diagnosis of Diarrhoea in Emergency Rooms
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