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

Primary Purpose

Staphylococcus Aureus

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Decolonization by nasal Octinidin treatment and skin washings
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Staphylococcus Aureus focused on measuring staphylococcus aureus, nosocomial infection, decolonization, emergency department

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Sites / Locations

  • Charité Universitätsmedizin - BerlinRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Emergency Department patients

Arm Description

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.

Outcomes

Primary Outcome Measures

MSSA/MRSA prevalence in a general ED-population
number of patients with a positive POC-test result for nasal/oral MSSA/MRSA
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.

Secondary Outcome Measures

Full Information

First Posted
May 8, 2017
Last Updated
July 17, 2017
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT03220386
Brief Title
Methicillin-sensitive and Methicillin-resistant Staphylococcus Aureus (MSSA/MRSA) - Point-of-care-testing (POCT) in Clinical Decision Making
Acronym
EPICS-6
Official Title
Methicillin-sensitive and Methicillin-resistant Staphylococcus Aureus (MSSA/MRSA) - Point-of-care-testing (POCT) in Clinical Decision Making
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Anticipated)
Study Completion Date
August 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Staphylococcus Aureus
Keywords
staphylococcus aureus, nosocomial infection, decolonization, emergency department

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients screened positive for nasal MSSA or MRSA colonization during their treatment in the emergency department receive a standardized decolonization Treatment (Octinidin nasal ointment and skin washing)
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Emergency Department patients
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Decolonization by nasal Octinidin treatment and skin washings
Intervention Description
Patients receive nasal Octinidin treatment and skin washings for five consecutive days
Primary Outcome Measure Information:
Title
MSSA/MRSA prevalence in a general ED-population
Description
number of patients with a positive POC-test result for nasal/oral MSSA/MRSA
Time Frame
on admission to the ED
Title
MSSA/MRSA in-hospital infection rates
Description
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.
Time Frame
at discharge from hospital for up to 90 days after admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >= 18 years Emergency Department (ED) visit in one of the participating EDs Exclusion Criteria: none
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Möckel, PhD, MD
Phone
+49 30 450 553 472
Email
martin.moeckel@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Slagman, VMD, MSc
Phone
+49 30 450 665 659
Email
anna.slagman@charite.de
Facility Information:
Facility Name
Charité Universitätsmedizin - Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Möckel, Prof. Dr.
Phone
0049 30 553472
Email
martin.moeckel@charite.de
First Name & Middle Initial & Last Name & Degree
Anna Slagman, Dr. MSc.
Phone
004930450553037
Email
anna.slagman@charite.de
First Name & Middle Initial & Last Name & Degree
Dorothee Riedlinger, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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