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

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: Gastroenteritis
• Intervention / Treatment: Diagnostic test: Gastro-intestinal panel by PCR

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

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 96 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

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

2

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	Diagnostic test: 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	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	Number and types of pathogens identified depending on the type of investigation	1 day
Number of PCR tests requested.	Number of patients for whom one, two or more PCR tests were requested.	1 month
Additional investigations	Number of patients who underwent additional investigations within 1 week after reception of the results of the initial investigations	1 week

Collaborators and Investigators

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

Study record dates

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

• Keywords: Gastroenteritis, panel by PCR, antibiotic use
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis
• 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