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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02685527
Enrollment
285
Registered
2016-02-18
Start date
2015-02-28
Completion date
2017-05-31
Last updated
2017-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

None listed

Sponsors

St. Franziskus Hospital
CollaboratorOTHER
Diakonissenkrankenhaus, Flensborg, Germany
CollaboratorUNKNOWN
Aabenraa Hospital
CollaboratorOTHER
University of Southern Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
faeces examination for norovirus and clostridium difficile bacteriaone week

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026