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

NCT ID: NCT02685527

Last Updated: 2017-05-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 285 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-05-31

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.

Conditions

Gastroenteritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Franziskus Hospital

OTHER

Sponsor Role: collaborator

Diakonissenkrankenhaus, Flensborg, Germany

UNKNOWN

Sponsor Role: collaborator

Aabenraa Hospital

OTHER

Sponsor Role: collaborator

University of Southern Denmark

OTHER

Sponsor Role: lead

Responsible Party

Christian Backer Mogensen

associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sygehus Soenderjylland

Aabenraa, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 30744568 (View on PubMed)

Other Identifiers

SHS-ED-02-2015

Identifier Type: -

Identifier Source: org_study_id