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

Gastroenteritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02685527
• Other study ID #: SHS-ED-02-2015
• Status: Completed
• Phase: N/A
• First received: August 26, 2015
• Last updated: May 17, 2017
• Start date: February 2015
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: May 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastroenteritis

Locations

Country	Name	City	State
Denmark	Sygehus Soenderjylland	Aabenraa

Sponsors (4)

Lead Sponsor	Collaborator
University of Southern Denmark	Aabenraa Hospital, Diakonissenkrankenhaus, Flensborg, Germany, St. Franziskus Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	faeces examination for norovirus and clostridium difficile bacteria		one week