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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
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diarrhoea

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 29, 2016
Last Updated
April 20, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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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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