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
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|
|Study Type :||Observational|
|Actual Enrollment :||285 participants|
|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|
- faeces examination for norovirus and clostridium difficile bacteria [ Time Frame: one week ]
Biospecimen Retention: Samples Without DNA
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
|Aabenraa, Denmark, 6200|