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

Gastroenteritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03551340
• Other study ID #: 2017-02042
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: March 30, 2020

Study information

• Verified date: October 2020
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: March 30, 2020
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastroenteritis

Intervention

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

Locations

Country	Name	City	State
Switzerland	Department of Outpatient Care and Community Medicine, University Hospital of Lausanne	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pathogens identified	Number and types of pathogens identified depending on the type of investigation	1 day
Secondary	Number of PCR tests requested.	Number of patients for whom one, two or more PCR tests were requested.	1 month
Secondary	Additional investigations	Number of patients who underwent additional investigations within 1 week after reception of the results of the initial investigations	1 week