Acute Gastroenteritis: Development of PCR Analysis and Algorithm for Fast Clarification of Isolation Indication

Acute Gastroenteritis: Development of PCR Analysis and Algorithm/Criteria for Fast Clarification of Isolation Indication

Isolation of contagious patients is expensive, requires more caregiver time, most of the patients perceive isolation as a mental strain and it has been shown that the level of care and observation is lower than in a normal ward. But isolation of contagious patients is necessary to protect other patients, hospital staff and relatives to prevent spreading of infection and, in worst case out-break.

There are different isolation regimes available depending on causative agent and mode of transmission. A community-acquired acute gastroenteritis (GE) is most often caused by Norovirus while a hospital-acquired acute GE is often caused by toxin producing Clostridium difficile. Patients infected with Norovirus or Clostridium difficile have to be isolated in single rooms with strict contact precautions. Patients infected with acute GE caused by other pathogens can be isolated in a multi-bed room if there is a private toilet.

However, at the time of arrival to hospital it is not known if the patient is contagious. The indication of isolation has to be made based of a clinical evaluation in risk of isolating to few or too many patients.

Aim of the study:

To identify anamnestic, clinical and paraclinical variables that can be used as indicators of the aetiology of infectious GE, thus giving an indication for isolation.

To clinically evaluate a combined RNA (Norovirus) and DNA (Clostridium difficile) fast PCR analysis test to identify infectious GE compared to gold standard methods.

Study Overview

• Status: Completed
• Conditions: Gastroenteritis

• Study Type: Observational
• Enrollment (Actual): 285

Contacts and Locations

Study Locations

• Denmark
  • Aabenraa, Denmark, 6200
    • Sygehus Soenderjylland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Acutely admitted patients that contact an emergency department of the Hospital of Southern Denmark or St. Franziskus Hospital, Flensburg, Germany or Diakonissenkrankenhaus, Flensburg, Germany with symptoms of acute gastroenteritis.

Description

Inclusion Criteria:

• acutely admitted
• more than three Loose stool, or lest than three Loose stools and vomiting within the last three weeks

Exclusion Criteria:

• age under 18 years

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
faeces examination for norovirus and clostridium difficile bacteria	one week

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: St. Franziskus Hospital; Diakonissenkrankenhaus, Flensborg, Germany; Aabenraa Hospital

Publications and helpful links

General Publications

• Skyum F, Pedersen C, Andersen V, Chen M, Franke A, Petersen D, Ries W, Mogensen CB. Risk factors for contagious gastroenteritis in adult patients with diarrhoea in the emergency department - a prospective observational multicentre study. BMC Infect Dis. 2019 Feb 11;19(1):133. doi: 10.1186/s12879-019-3754-4.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: August 26, 2015
• First Submitted That Met QC Criteria: February 17, 2016
• First Posted (Estimate): February 18, 2016

Study Record Updates

• Last Update Posted (Actual): May 18, 2017
• Last Update Submitted That Met QC Criteria: May 17, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis
• Other Study ID Numbers: SHS-ED-02-2015