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

NCT ID: NCT03220386

Last Updated: 2017-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-08-01

Brief Summary

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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

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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.

Conditions

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Staphylococcus Aureus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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)
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Decolonization by nasal Octinidin treatment and skin washings

Intervention Type OTHER

Patients receive nasal Octinidin treatment and skin washings for five consecutive days

Interventions

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Decolonization by nasal Octinidin treatment and skin washings

Patients receive nasal Octinidin treatment and skin washings for five consecutive days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Martin Moeckel

Professor Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Charité Universitätsmedizin - Berlin

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Martin Möckel, PhD, MD

Role: CONTACT

+49 30 450 553 472

Anna Slagman, VMD, MSc

Role: CONTACT

+49 30 450 665 659

Facility Contacts

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Martin Möckel, Prof. Dr.

Role: primary

0049 30 553472

Anna Slagman, Dr. MSc.

Role: backup

004930450553037

Other Identifiers

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EA1/055/17

Identifier Type: -

Identifier Source: org_study_id

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