- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03551340
Impact of the Introduction of a Gastro-intestinal Panel by Polymerase Chain Reaction (PCR).
Impact of the Introduction of a Gastro-intestinal Panel by PCR on the Treatment of Patients With Gastroenteritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Lausanne, Switzerland, 1011
- Department of Outpatient Care and Community Medicine, University Hospital of Lausanne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
Ambulatory patients who consulted the University Hospital of Lausanne between July 2016 and May 2017, and were investigated by traditional methods (stool microscopy and culture).
Ambulatory patients who consulted the University Hospital of Lausanne between July 2017 and May 2018 and had stool investigations by a gastro-intestinal panel.
Exclusion criteria:
Patients for whom there ia record in the file that they do not accept that their data are used for research purposes.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Traditional methods
Patients, who consulted for gastro-intestinal symptoms between July 2016 and May 2017, and were investigated by traditional methods (stool microscopy and/or culture).
|
|
Gastro-intestinal panel by PCR
Patients, who consulted for gastro-intestinal symptoms between July 2017 and May 2018,and were investigated by a gastro-intestinal panel by PCR
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The study will evaluate the change in medical management with the replacement of traditional stool investigations (microscopy and culture) by the new gastrointestinal multiplex PCR panels
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prescription of antibiotics
Time Frame: Within 1 week of availability of stool result
|
Number of patients receiving a prescription of antibiotics depending on the type of investigation
|
Within 1 week of availability of stool result
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathogens identified
Time Frame: 1 day
|
Number and types of pathogens identified depending on the type of investigation
|
1 day
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Number of PCR tests requested.
Time Frame: 1 month
|
Number of patients for whom one, two or more PCR tests were requested.
|
1 month
|
Additional investigations
Time Frame: 1 week
|
Number of patients who underwent additional investigations within 1 week after reception of the results of the initial investigations
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1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Serge de Valliere, MD,MSc, University of Lausanne Hospitals
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-02042
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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