Clinical trial NCT03551340: Impact of the Introduction of a Gastro-intestinal Panel by Polymerase Chain Reaction (PCR).
Official title: Impact of the Introduction of a Gastro-intestinal Panel by PCR on the Treatment of Patients With Gastroenteritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroenteritis
Keywords: Gastroenteritis, panel by PCR, antibiotic use
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2018-06-11
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prescription of antibiotics
timeFrame: Within 1 week of availability of stool result
Secondary outcomes:
measure: Pathogens identified
timeFrame: 1 day
measure: Number of PCR tests requested.
timeFrame: 1 month
measure: Additional investigations
timeFrame: 1 week
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Department of Outpatient Care and Community Medicine, University Hospital of Lausanne
Study officials:
affiliation: University of Lausanne Hospitals
name: Serge de Valliere, MD,MSc
role: PRINCIPAL_INVESTIGATOR
References: