Impact of the Introduction of a Gastro-intestinal Panel by Polymerase Chain Reaction (PCR).

October 22, 2020 updated by: Serge de Valliere, University of Lausanne Hospitals

Impact of the Introduction of a Gastro-intestinal Panel by PCR on the Treatment of Patients With Gastroenteritis

Evaluation of the impact of the introduction of multiplex PCR panels on the clinical management of patients with gastroenteritis at the University Hospital of Lausanne, Switzerland.

Study Overview

Status

Completed

Conditions

Detailed Description

Gastrointestinal multiplex PCR panels have been introduced in clinical practice several years ago, but the impact on the management of patients is yet unknown. The investigators are interested to evaluate if the multiplex PCR panels introduced at the University Hospital of Lausanne in July 2017 modified the usual medical care and in particular the prescription of anti-infectious treatments. The high sensitivity of the multiplex PCR panels should allow a more precise diagnosis of the etiology of the gastrointestinal symptoms of the patients than the traditional methods of stool culture and microscopy. The investigators expect therefore to observe a modification of the proportion of patients receiving anti-infectious treatment, but it is uncertain if it will lead to an increase or a decrease in the use of antibiotics. On one hand antibiotics could be prescribed more often due to a greater and faster detection of enteropathogens. On the other hand antibiotics could be prescribed less often due to more precise diagnosis, showing that viruses and certain bacteria do not require antibiotic treatment.

Study Type

Observational

Enrollment (Actual)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Lausanne, Switzerland, 1011
        • Department of Outpatient Care and Community Medicine, University Hospital of Lausanne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients consulting the emergency department of the University Hospital of Lausanne for gastro-intestinal symptoms suggestive of an infectious origin

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

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
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
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Serge de Valliere, MD,MSc, University of Lausanne Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

March 30, 2020

Study Registration Dates

First Submitted

May 28, 2018

First Submitted That Met QC Criteria

May 28, 2018

First Posted (Actual)

June 11, 2018

Study Record Updates

Last Update Posted (Actual)

October 23, 2020

Last Update Submitted That Met QC Criteria

October 22, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2017-02042

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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