Clinical trial NCT02685527: Acute Gastroenteritis: Development of PCR Analysis and Algorithm for Fast Clarification of Isolation Indication
Official title: Acute Gastroenteritis: Development of PCR Analysis and Algorithm/Criteria for Fast Clarification of Isolation Indication
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroenteritis
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: St. Franziskus Hospital
name: Diakonissenkrankenhaus, Flensborg, Germany
name: Aabenraa Hospital
First posted: 2016-02-18
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: faeces examination for norovirus and clostridium difficile bacteria
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Aabenraa
country: Denmark
facility: Sygehus Soenderjylland
Study officials:
References:
citation: 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.