Methicillin-sensitive and Methicillin-resistant Staphylococcus Aureus (MSSA/MRSA) - Point-of-care-testing (POCT) in Clinical Decision Making (EPICS-6)

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.

Study Overview

• Status: Unknown
• Conditions: Staphylococcus Aureus
• Intervention / Treatment: Other: Decolonization by nasal Octinidin treatment and skin washings

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin Möckel, PhD, MD; Phone Number: +49 30 450 553 472; Email: martin.moeckel@charite.de
• Study Contact Backup: Name: Anna Slagman, VMD, MSc; Phone Number: +49 30 450 665 659; Email: anna.slagman@charite.de

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Charité Universitätsmedizin - Berlin
    • Contact: Martin Möckel, Prof. Dr.; Phone Number: 0049 30 553472; Email: martin.moeckel@charite.de
    • Contact: Anna Slagman, Dr. MSc.; Phone Number: 004930450553037; Email: anna.slagman@charite.de
    • Sub-Investigator: Dorothee Riedlinger, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age >= 18 years
• Emergency Department (ED) visit in one of the participating EDs

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Emergency Department patients; All patients will be tested for nasal MSSA/MRSA-colonization. Patients tested positive for nasal MSSA/MRSA-colonization receive a decolonization treatment. This treatment includes octinidin nasal treatment and skin washings.	Other: Decolonization by nasal Octinidin treatment and skin washings; Patients receive nasal Octinidin treatment and skin washings for five consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2017
• Primary Completion (ANTICIPATED): August 1, 2018
• Study Completion (ANTICIPATED): August 1, 2018

Study Registration Dates

• First Submitted: May 8, 2017
• First Submitted That Met QC Criteria: July 17, 2017
• First Posted (ACTUAL): July 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 18, 2017
• Last Update Submitted That Met QC Criteria: July 17, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: emergency department; staphylococcus aureus; nosocomial infection; decolonization
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Staphylococcal Infections
• Other Study ID Numbers: EA1/055/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No