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OpenTrials
Completed

NCT Number: NCT02685527

Acute Gastroenteritis: Development of PCR Analysis and Algorithm 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sygehus Soenderjylland

Aabenraa, 6200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. faeces examination for norovirus and clostridium difficile bacteria

    Time frame: one week

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Aabenraa Hospital
  • Diakonissenkrankenhaus, Flensborg, Germany
  • St. Franziskus Hospital

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 18, 2016
Registry last updated
May 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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