NCT03551340

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 11, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

October 23, 2020

Status Verified

October 1, 2020

Enrollment Period

10 months

First QC Date

May 28, 2018

Last Update Submit

October 22, 2020

Conditions

Keywords

Gastroenteritis, panel by PCR, antibiotic use

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Pathogens identified

    1 day

  • Number of PCR tests requested.

    1 month

  • Additional investigations

    1 week

Study Arms (2)

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

Interventions

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

Gastro-intestinal panel by PCR

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients consulting the emergency department of the University Hospital of Lausanne for gastro-intestinal symptoms suggestive of an infectious origin

You may qualify if:

  • 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.

You may not qualify if:

  • Patients for whom there ia record in the file that they do not accept that their data are used for research purposes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lausanne, 1011, Switzerland

Location

MeSH Terms

Conditions

Gastroenteritis

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Serge de Valliere, MD,MSc

    University of Lausanne Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD & MER

Study Record Dates

First Submitted

May 28, 2018

First Posted

June 11, 2018

Study Start

March 1, 2018

Primary Completion

December 31, 2018

Study Completion

March 30, 2020

Last Updated

October 23, 2020

Record last verified: 2020-10

Locations