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

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ClinicalTrials.gov Identifier: NCT02685527
Recruitment Status : Completed
First Posted : February 18, 2016
Last Update Posted : May 18, 2017
Sponsor:
Collaborators:
St. Franziskus Hospital
Diakonissenkrankenhaus, Flensborg, Germany
Aabenraa Hospital
Information provided by (Responsible Party):
Christian Backer Mogensen, University of Southern Denmark

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.


Condition or disease
Gastroenteritis

Study Type : Observational
Actual Enrollment : 285 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Acute Gastroenteritis: Development of PCR Analysis and Algorithm/Criteria for Fast Clarification of Isolation Indication
Study Start Date : February 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gastroenteritis




Primary Outcome Measures :
  1. faeces examination for norovirus and clostridium difficile bacteria [ Time Frame: one week ]

Biospecimen Retention:   Samples Without DNA
feces for bacterial and virus determination


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02685527


Locations
Denmark
Sygehus Soenderjylland
Aabenraa, Denmark, 6200
Sponsors and Collaborators
University of Southern Denmark
St. Franziskus Hospital
Diakonissenkrankenhaus, Flensborg, Germany
Aabenraa Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christian Backer Mogensen, associate professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT02685527     History of Changes
Other Study ID Numbers: SHS-ED-02-2015
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases