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Completed

NCT Number: NCT03551340

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Lausanne, 1011, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gastro-intestinal panel by PCR

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Pathogens identified

    Time frame: 1 day

    Number and types of pathogens identified depending on the type of investigation

  2. Number of PCR tests requested.

    Time frame: 1 month

    Number of patients for whom one, two or more PCR tests were requested.

  3. 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

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2020
First posted
Jun 11, 2018
Registry last updated
Oct 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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