Methicillin-sensitive and Methicillin-resistant Staphylococcus Aureus (MSSA/MRSA) - Point-of-care-testing (POCT) in Clinical Decision Making

Staphylococcus Aureus Clinical Trial

— EPICS-6  

Official title:

Methicillin-sensitive and Methicillin-resistant Staphylococcus Aureus (MSSA/MRSA) - Point-of-care-testing (POCT) in Clinical Decision Making

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03220386
• Other study ID #: EA1/055/17
• Status: Recruiting
• Phase: N/A
• First received: May 8, 2017
• Last updated: July 17, 2017
• Start date: May 1, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: July 2017
• Source: Charite University, Berlin, Germany
• Contact: Martin Möckel, PhD, MD
• Phone: +49 30 450 553 472
• Email: martin.moeckel[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study EPICS-6 consists of three study phases. Emergency Department patients are screened for nasal and pharyngeal colonisation with Methicillin sensitive and Methicillin resistant Staphylococcus aureus (MSSA/MRSA) using a point-of-care (POC)-PCR-testing method (cobas®LIAT®-System, Roche Molecular Systems Inc.) The first aim of this study is to describe the prevalence of MSSA/MRSA-colonisation in a routine cohort of Emergency Department patients. The second aim is to determine the impact of POC-guided decolonisation as compared to conventional laboratory testing on in-hospital infection rates with MSSA/MRSA in a pre-post-comparison study.

Description:

The study EPICS-6 consists of three study phases. In phase one the novel POC-PCR-testing method for MSSA/MRSA-proof (cobas®LIAT®-System, Roche Molecular Systems Inc.) is technically established and integrated in Emergency Department procedures. After evaluation of processes and sample handling the second phase of this study assesses the prevalence of positive MSSA/MRSA-POC-testing in the general ED-population and in different risk groups. Based on the results of the previous study phases, the final phase comprises an interventional pre-post-comparison study. The interventional study assesses the impact of POC-result guided early decolonisation of MSSA/MRSA-colonized patients on in-hospital infection rates with MSSA/MRSA.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

• Age >= 18 years

• Emergency Department (ED) visit in one of the participating EDs

Exclusion Criteria:

Related Conditions & MeSH terms

• Staphylococcal Infections
• Staphylococcus Aureus

Intervention

Other:
• Decolonization by nasal Octinidin treatment and skin washings
Patients receive nasal Octinidin treatment and skin washings for five consecutive days

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin - Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MSSA/MRSA prevalence in a general ED-population	number of patients with a positive POC-test result for nasal/oral MSSA/MRSA	on admission to the ED
Primary	MSSA/MRSA in-hospital infection rates	number of in-hospital MSSA/MRSA infections in patients with known nasal/oral colonization with MSSA/MRSA. This outcome measure will be assessed for the time period between admission and discharge from hospital for up to 90 days after study inclusion. It will be assessed by routine MSSA/MRSA in-hospital testing and the respective test results will be retrieved from the hospital Information system.	at discharge from hospital for up to 90 days after admission