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

NCT ID: NCT03551340

Last Updated: 2020-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2020-03-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gastroenteritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

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

Gastro-intestinal panel by PCR

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Lausanne Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Serge de Valliere

PD & MER

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Serge de Valliere, MD,MSc

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne Hospitals

Locations

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Department of Outpatient Care and Community Medicine, University Hospital of Lausanne

Lausanne, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2017-02042

Identifier Type: -

Identifier Source: org_study_id

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